PROD. NO. 01-132 - SUTURE REMOVAL KIT— 510(k) K964827

Name: FDA 510(k) clearance K964827
Creator: U.S. Food and Drug Administration
Published: 1997-02-14

Substantially Equivalent

Continental Medical Laboratories, Inc.

FDA 510(k) clearance K964827 for PROD. NO. 01-132 - SUTURE REMOVAL KIT, Substantially Equivalent on 1997-02-14. Applicant: Continental Medical Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Continental Medical Laboratories, Inc.
Product code: Code MCZ
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1996-12-02
Decision date: 1997-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waterford, WI, US

Download summary PDF View on FDA.gov ↗

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