MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (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 Modified Coated Vicryl Plus Antibacterial (polyglactin 910) Synthetic Absorbable Suture.

Pre-market Notification Details

• Device ID: K032420
• 510k Number: K032420
• Device Name: MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
• Classification: Suture, Absorbable, Synthetic, Polyglycolic Acid
• Applicant: ETHICON, INC. P.O BOX 151, ROUTE 22 WEST Somerville, NJ 08876
• Contact: Rey Librojo
• Correspondent: Rey Librojo; ETHICON, INC. P.O BOX 151, ROUTE 22 WEST 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: 2003-08-05
• Decision Date: 2003-10-22
• Summary: summary

NIH GUDID Devices

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