COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE

Suture, Absorbable, Synthetic, Polyglycolic Acid

ETHICON, INC.

The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Coated Vicryl Plus Antimicrobial (polyglactin 910) Synthetic Absorbable Suture.

Pre-market Notification Details

• Device ID: K132580
• 510k Number: K132580
• Device Name: COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
• Classification: Suture, Absorbable, Synthetic, Polyglycolic Acid
• Applicant: ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151
• Contact: Peter Cecchini
• Correspondent: Peter Cecchini; ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151
• Product Code: GAM
• CFR Regulation Number: 878.4493 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2013-08-16
• Decision Date: 2014-02-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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