BOUFFANT CAP— 510(k) K953878

Name: FDA 510(k) clearance K953878
Creator: U.S. Food and Drug Administration
Published: 1996-01-05

Substantially Equivalent

American Threshold Industries, Inc.

FDA 510(k) clearance K953878 for BOUFFANT CAP, Substantially Equivalent on 1996-01-05. Applicant: American Threshold Industries, Inc.. Device class: 1.

Clearance details

Applicant: American Threshold Industries, Inc.
Product code: Code FYF
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1995-08-16
Decision date: 1996-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Enka, NC, US

Download summary PDF View on FDA.gov ↗

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K952115 — BARRIER GOWN, KOOL-GARD BACKLESS GOWN1995-09-25
K952116 — COVER GOWN1995-09-05

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