COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH

Mesh, Surgical, Polymeric

UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC

The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Coated Surgipro(tm) Polypropylene Surgical Mesh.

Pre-market Notification Details

• Device ID: K915526
• 510k Number: K915526
• Device Name: COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH
• Classification: Mesh, Surgical, Polymeric
• Applicant: UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856
• Contact: Steve Reitzler
• Correspondent: Steve Reitzler; UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856
• Product Code: FTL
• CFR Regulation Number: 878.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-12-10
• Decision Date: 1992-05-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20884521101446	K915526	000
10884521101340	K915526	000
20884521101354	K915526	000
20884521101361	K915526	000
20884521101378	K915526	000
20884521101385	K915526	000
20884521101392	K915526	000
10884521101401	K915526	000
10884521101418	K915526	000
20884521101422	K915526	000
20884521101439	K915526	000
10884521101333	K915526	000