AUDI-SIL EARMOLD MATERIAL— 510(k) K771615

Name: FDA 510(k) clearance K771615
Creator: U.S. Food and Drug Administration
Published: 1977-08-30

Substantially Equivalent

Coe Laboratories, Inc.

FDA 510(k) clearance K771615 for AUDI-SIL EARMOLD MATERIAL, Substantially Equivalent on 1977-08-30. Applicant: Coe Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Coe Laboratories, Inc.
Product code: Code ESH
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 1977-08-24
Decision date: 1977-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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