FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE

Suture, Nonabsorbable, Synthetic, Polyethylene

Teleflex Medical, Inc.

The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Force Fiber Black Co-braid Polyethylene Non-absorbable Surgical Suture.

Pre-market Notification Details

• Device ID: K070673
• 510k Number: K070673
• Device Name: FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE
• Classification: Suture, Nonabsorbable, Synthetic, Polyethylene
• Applicant: Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709
• Contact: Elizabeth Landon
• Correspondent: Elizabeth Landon; Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709
• Product Code: GAT
• CFR Regulation Number: 878.5000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-03-12
• Decision Date: 2007-04-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20817470007309	K070673	000
20817470007293	K070673	000
20817470007286	K070673	000
20817470007279	K070673	000
20817470007262	K070673	000
20817470007255	K070673	000