REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS— 510(k) K070930

Name: FDA 510(k) clearance K070930
Creator: U.S. Food and Drug Administration
Published: 2007-10-18

Substantially Equivalent

Sterilmed, Inc.

FDA 510(k) clearance K070930 for REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS, Substantially Equivalent on 2007-10-18. Applicant: Sterilmed, Inc.. Device class: 2.

Clearance details

Applicant: Sterilmed, Inc.
Product code: Code NLL
Device class: Class 2
Regulation: 21 CFR 878.4750
Advisory panel: General, Plastic Surgery
Date received: 2007-04-03
Decision date: 2007-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

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