PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable 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 Mesh Non-absorbable Synthetic Surgical Mesh, Prolene (polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh.

Pre-market Notification Details

• Device ID: K180829
• 510k Number: K180829
• Device Name: PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh
• Classification: Mesh, Surgical, Polymeric
• Applicant: Ethicon, Inc Route 22 West, P.O. Box 151 Somerville, NJ 08876
• Contact: Stephanie Saati
• Correspondent: Stephanie Saati; Ethicon, Inc Route 22 West, P.O. Box 151 Somerville, NJ 08876
• Product Code: FTL
• CFR Regulation Number: 878.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-03-30
• Decision Date: 2018-06-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10705031048935	K180829	000
20705031048987	K180829	000
20705031048956	K180829	000