INTEC FULL FACE SHIELD— 510(k) K946003

Substantially Equivalent

Intec Industries, Inc.

FDA 510(k) clearance K946003 for INTEC FULL FACE SHIELD, Substantially Equivalent on 1995-06-28. Applicant: Intec Industries, Inc.. Device class: 1.

Clearance details

Applicant: Intec Industries, Inc.
Product code: Code LYU
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1994-12-09
Decision date: 1995-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, AL, US

Download summary PDF View on FDA.gov ↗

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