MONOCRYL PLUS ANTIBACTERIAL 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 Monocryl Plus Antibacterial Suture.

Pre-market Notification Details

• Device ID: K050845
• 510k Number: K050845
• Device Name: MONOCRYL PLUS ANTIBACTERIAL SUTURE
• Classification: Suture, Absorbable, Synthetic, Polyglycolic Acid
• Applicant: ETHICON, INC. ROUTE 22 WEST P.O.BOX 151 Somerville, NJ 08876
• Contact: Jennifer M Paine
• Correspondent: Jennifer M Paine; ETHICON, INC. ROUTE 22 WEST P.O.BOX 151 Somerville, NJ 08876
• Product Code: GAM
• CFR Regulation Number: 878.4493 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2005-04-04
• Decision Date: 2005-06-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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