AMERICAN BRAIN RETRACTOR COVER— 510(k) K872951

Name: FDA 510(k) clearance K872951
Creator: U.S. Food and Drug Administration
Published: 1987-09-16

Substantially Equivalent

American Silk Sutures, Inc.

FDA 510(k) clearance K872951 for AMERICAN BRAIN RETRACTOR COVER, Substantially Equivalent on 1987-09-16. Applicant: American Silk Sutures, Inc.. Device class: 1.

Clearance details

Applicant: American Silk Sutures, Inc.
Product code: Code GET
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1987-07-28
Decision date: 1987-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lynn, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.