REPEL(TM) LITE CUT RESISTANT GLOVE LINERS— 510(k) K914077

Name: FDA 510(k) clearance K914077
Creator: U.S. Food and Drug Administration
Published: 1991-12-02

Substantially Equivalent

Depuy-Raynham

FDA 510(k) clearance K914077 for REPEL(TM) LITE CUT RESISTANT GLOVE LINERS, Substantially Equivalent on 1991-12-02. Applicant: Depuy-Raynham. Device class: 1.

Clearance details

Applicant: Depuy-Raynham
Product code: Code LYU
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1991-09-11
Decision date: 1991-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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