AMCON SLIP IN MYDRIATIC SUNGLASSES— 510(k) K942407

Name: FDA 510(k) clearance K942407
Creator: U.S. Food and Drug Administration
Published: 1994-06-06

Substantially Equivalent

Amcon Laboratories, Inc.

FDA 510(k) clearance K942407 for AMCON SLIP IN MYDRIATIC SUNGLASSES, Substantially Equivalent on 1994-06-06. Applicant: Amcon Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Amcon Laboratories, Inc.
Product code: Code HOY
Device class: Class 1
Regulation: 21 CFR 886.4750
Advisory panel: Ophthalmic
Date received: 1994-05-20
Decision date: 1994-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Issaquah, WA, US

Download summary PDF View on FDA.gov ↗

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