NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES

Suture, Nonabsorbable, Synthetic, Polyethylene

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 Novafil** And Vascufil** Sterile Synthetic Non-absorbable Sutures.

Pre-market Notification Details

• Device ID: K990952
• 510k Number: K990952
• Device Name: NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES
• Classification: Suture, Nonabsorbable, Synthetic, Polyethylene
• Applicant: UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856
• Contact: Victor M Clavelli
• Correspondent: Victor M Clavelli; UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856
• Product Code: GAT
• CFR Regulation Number: 878.5000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-03-22
• Decision Date: 1999-04-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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