AMERICAN BURN SHEET— 510(k) K922143

Name: FDA 510(k) clearance K922143
Creator: U.S. Food and Drug Administration
Published: 1992-08-10

Substantially Equivalent

American Silk Sutures, Inc.

FDA 510(k) clearance K922143 for AMERICAN BURN SHEET, Substantially Equivalent on 1992-08-10. Applicant: American Silk Sutures, Inc.. Device class: 1.

Clearance details

Applicant: American Silk Sutures, Inc.
Product code: Code KME
Device class: Class 1
Regulation: 21 CFR 880.6060
Advisory panel: General Hospital
Date received: 1992-05-06
Decision date: 1992-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lynn, MA, US

Download summary PDF View on FDA.gov ↗

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