PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH

Mesh, Surgical, Polymeric

ETHICON, INC.

The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Prolene (polypropylene) 3d Patch, Nonabsorbable Synthetic Surgical Mesh.

Pre-market Notification Details

• Device ID: K010722
• 510k Number: K010722
• Device Name: PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH
• Classification: Mesh, Surgical, Polymeric
• Applicant: ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151
• Contact: Gregory R Jones
• Correspondent: Gregory R Jones; ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151
• Product Code: FTL
• CFR Regulation Number: 878.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-03-12
• Decision Date: 2001-04-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20705031005133	K010722	000