HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL

K973927 · Hyunjae Corp. · ESD · Dec 11, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K973927
• Device Name: HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL
• Applicant: Hyunjae Corp.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Dec 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3300
• Device Class: Class 1

Intended Use

To obtain accurate imprint of an individual on ear Canal.

Device Story

NuSil Earmold Impression Material is a substance used by hearing healthcare professionals to capture the physical geometry of a patient's ear canal. The material is applied into the ear canal, where it cures to form a negative impression. This impression is then used by laboratories to fabricate custom-fit earmolds for hearing aids or hearing protection. The device facilitates the creation of personalized ear-worn devices, ensuring proper fit and acoustic seal for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Impression material for ear canal molding. Class I device under 21 CFR 874.3300. No specific material standards or software components described.

Indications for Use

Indicated for obtaining an accurate imprint of an individual's ear canal for the purpose of creating earmolds.

Regulatory Classification

Identification

An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

> DEC I I 1997

Daniel Cho President HYUNJAE CORPORATION 8 South End Plaza New Milford, CT 06776

Re: K973927 Hyuniae Corporation Nusil Earmold Impression Material Dated: October 5, 1997 Received: October 15, 1997 Regulatory Class: I 21 CFR 874.3300/Procode: 77 ESD

Dear Mr. Cho:

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 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 requirement, 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 does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 (2) CFR Part 801 and additionally 809-10.for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

W. Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CDRH DRAERD

ത്രവുമ

Page__________________________________________________________________________________________________________________________________________________________________________

510(1) Number (if known): K973927
Device Name: Hyunjae Corporation NuSil Ear mold
Impression material
Indications For Use:

To obtain accurate imprint of
an individual on ear Canal.

(PL) ASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEE! JED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973927

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

(Optional Format 1-2-96)