SMITH & NEPHEW ULTRATAPE

Suture, Nonabsorbable, Synthetic, Polyethylene

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Ultratape.

Pre-market Notification Details

• Device ID: K132357
• 510k Number: K132357
• Device Name: SMITH & NEPHEW ULTRATAPE
• Classification: Suture, Nonabsorbable, Synthetic, Polyethylene
• Applicant: SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810
• Contact: Melody Bi
• Correspondent: Melody Bi; SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810
• Product Code: GAT
• CFR Regulation Number: 878.5000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-07-29
• Decision Date: 2013-10-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20885556727748	K132357	000
20885556727731	K132357	000
20885556727724	K132357	000