MODIFICATION OF SURGICAL EYESHIELD MASK— 510(k) K934085

Name: FDA 510(k) clearance K934085
Creator: U.S. Food and Drug Administration
Published: 1993-11-12

Substantially Equivalent

American Threshold Industries, Inc.

FDA 510(k) clearance K934085 for MODIFICATION OF SURGICAL EYESHIELD MASK, Substantially Equivalent on 1993-11-12. Applicant: American Threshold Industries, Inc.. Device class: 1.

Clearance details

Applicant: American Threshold Industries, Inc.
Product code: Code HOY
Device class: Class 1
Regulation: 21 CFR 886.4750
Advisory panel: Ophthalmic
Date received: 1993-08-20
Decision date: 1993-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Enka, NC, US

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