NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE

Suture, Nonabsorbable, Synthetic, Polypropylene

TYCO HEALTHCARE GROUP, LP

The following data is part of a premarket notification filed by Tyco Healthcare Group, Lp with the FDA for Nonabsorbable Polypropylene Surgical Suture.

Pre-market Notification Details

• Device ID: K010909
• 510k Number: K010909
• Device Name: NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
• Classification: Suture, Nonabsorbable, Synthetic, Polypropylene
• Applicant: TYCO HEALTHCARE GROUP, LP 150 GLOVER AVE. Norwalk, CT 06856
• Contact: Robert Zott
• Correspondent: Robert Zott; TYCO HEALTHCARE GROUP, LP 150 GLOVER AVE. Norwalk, CT 06856
• Product Code: GAW
• CFR Regulation Number: 878.5010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-03-26
• Decision Date: 2001-04-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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