PRONOVA NONABSORBABLE SUTURE, USP

Suture, Nonabsorbable, Synthetic, Polypropylene

ETHICON, INC.

The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Pronova Nonabsorbable Suture, Usp.

Pre-market Notification Details

• Device ID: K001625
• 510k Number: K001625
• Device Name: PRONOVA NONABSORBABLE SUTURE, USP
• Classification: Suture, Nonabsorbable, Synthetic, Polypropylene
• Applicant: ETHICON, INC. P.O BOX 151, ROUTE 22 WEST Somerville, NJ 08876
• Contact: Peter M Cecchini
• Correspondent: Peter M Cecchini; ETHICON, INC. P.O BOX 151, ROUTE 22 WEST Somerville, NJ 08876
• Product Code: GAW
• CFR Regulation Number: 878.5010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-05-17
• Decision Date: 2000-07-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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