COVAMESH

Mesh, Surgical, Polymeric

BIOMUP S.A.

The following data is part of a premarket notification filed by Biomup S.a. with the FDA for Covamesh.

Pre-market Notification Details

• Device ID: K130428
• 510k Number: K130428
• Device Name: COVAMESH
• Classification: Mesh, Surgical, Polymeric
• Applicant: BIOMUP S.A. 8 ALLEE IRENE JOLIOT-CURIE St-priest, FR 69800
• Contact: Valerie Centis
• Correspondent: Valerie Centis; BIOMUP S.A. 8 ALLEE IRENE JOLIOT-CURIE St-priest, FR 69800
• Product Code: FTL
• CFR Regulation Number: 878.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-02-20
• Decision Date: 2013-10-25
• Summary: summary