← Product Code [EMX](/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX) · K983276 # HYDROFERA BACTERISTATIC NASAL DRESSING (K983276) _Hydrofera, LLC · EMX · Sep 14, 1999 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K983276 ## Device Facts - **Applicant:** Hydrofera, LLC - **Product Code:** [EMX](/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX.md) - **Decision Date:** Sep 14, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.4100 - **Device Class:** Class 1 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic ## Intended Use POST OPERATIVE PACKING AFTER SEPTAL RHINOPLASTIC, OR TURBINATE SURGERY. ## Device Story Hydrofera Bacteristatic Nasal Dressing is a post-operative nasal packing device. Used by surgeons in clinical settings following septal, rhinoplastic, or turbinate procedures. Functions as a physical dressing to manage the surgical site post-operation. Benefits include providing support and bacteriostatic properties to the nasal cavity during the healing process. ## Clinical Evidence No clinical data provided; substantial equivalence determination based on 510(k) regulatory review. ## Technological Characteristics Bacteriostatic nasal dressing; form factor designed for nasal cavity packing post-surgery. ## Regulatory Identification An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 1 4 1999 Ms. Heather S. Bond Director Polymer Technology Hydrofera, LLC 322 Main St., Suite 1101 Willimantic, CT 06226 Re: K983276 Device: Hydrofera Bacteristatic Nasal Dressing Dated: August 20, 1999 Received: August 23, 1999 Classification Regulation: 77 EMX, CFR 874.4100 Regulatory Class: II Dear Ms. Bond: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations . {1}------------------------------------------------ Page 2 - Ms. Heather S. Bond This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market. If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597. Sincerely yours, Alez L. Rosenthal A. Ralph Rosenthal, M.D. A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | Page of | | |---------|--| |---------|--| 510(k) Number (if known): ڀو83276-6-14982325 ्र के लिए क : Device Name: BACTERISTATIC NASAL DRESSING Indications For Use: POST OPERATIVE PACKING AFTER SEPTAL RHINOPLASTIC, OR TURBINATE SURGERY. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) C and the state of the states of the states Concurrence of CDRH, Office of Device Evaluation (ODE) | | (Division Sign-Off) | |---------------|--------------------------------| | | Division of Ophthalmic Devices | | 510(k) Number | K983276 | | Prescription Use (Per 21 CFR 801.109) | ✓ | |---------------------------------------|---------------------------------------------------| |---------------------------------------|---------------------------------------------------| OR Over-The-Counter Use_ (Optional Format 1-2-96). --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K983276](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EMX/K983276) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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