AESCULAP MONOMAX ABSORBABLE SUTURE— 510(k) K100876

Name: FDA 510(k) clearance K100876
Creator: U.S. Food and Drug Administration
Published: 2010-07-14

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K100876 for AESCULAP MONOMAX ABSORBABLE SUTURE, Substantially Equivalent on 2010-07-14. Applicant: Aesculap, Inc.. Device class: 2.

Clearance details

Applicant: Aesculap, Inc.
Product code: Code NWJ
Device class: Class 2
Regulation: 21 CFR 878.4494
Advisory panel: General, Plastic Surgery
Date received: 2010-03-30
Decision date: 2010-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, 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.