HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL— 510(k) K973927

Name: FDA 510(k) clearance K973927
Creator: U.S. Food and Drug Administration
Published: 1997-12-11

Substantially Equivalent

Hyunjae Corp.

FDA 510(k) clearance K973927 for HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL, Substantially Equivalent on 1997-12-11. Applicant: Hyunjae Corp.. Device class: 1.

Clearance details

Applicant: Hyunjae Corp.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1997-10-15
Decision date: 1997-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Milford, CT, US

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