← Product Code EFQ · K971075 # PRIMED PRIME-PLUS COTTON GAUZE SPONGES (K971075) _Primeline Medical Products, Inc. · EFQ · Jun 22, 1997 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K971075 ## Device Facts - **Applicant:** Primeline Medical Products, Inc. - **Product Code:** EFQ - **Decision Date:** Jun 22, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use Cotton Gauze Sponges are designed as single use, and general use medical devices in the management of wounds. ## Device Story Cotton gauze sponges used for wound management. Single-use, general-purpose medical device. Applied by clinicians to wounds to assist in management. Benefits include standard wound care utility. ## Clinical Evidence No clinical data. ## Technological Characteristics Cotton gauze material. Single-use form factor. ## 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} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 20 1997 Mr. Guy J. Plamondon President PrimeLine Medical Products, Inc. 2235 - 27 Avenue N.E. Calgary, Alberta T2E 7M4 Canada Re: K971075 Trade Name: priMED "Prime-Plus" Cotton Gauze Sponges Regulatory Class: Unclassified Product Code: EFQ Dated: March 18, 1997 Received: March 24, 1997 Dear Mr. Plamondon: 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 {1} Page 2 - Mr. Guy J. Plamondon the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA-finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device 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) 594-4595. Additionally, for questions on the promotion and advertising of your device, 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 toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, ![img-0.jpeg](img-0.jpeg) Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} 403 497 7670 PRIMEX CHINA GRP 880 P03 JUN 09 '97 14:55 # 7. STATEMENT OF INDICATIONS FOR USE 510 (K) NUMBER (if known): 971075 DEVICE NAME: PrimeLine Medical Products Inc. Cotton Gauze Sponges INDICATIONS FOR USE: Cotton Gauze Sponges are designed as single use, and general use medical devices in the management of wounds. Guy J. Plamondon, President PrimeLine Medical Products Inc. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General Restorative Devices 510(k) Number K97/075 Prescription Use ☑ (Per 21 CFR 801 109) OR Over-the-Counter Use Page 5 of 10 --- **Source:** [https://fda.innolitics.com/device/K971075](https://fda.innolitics.com/device/K971075) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com