PDS PLUS ANTIBACTERIAL SUTURE

Suture, Surgical, Absorbable, Polydioxanone

ETHICON, INC.

The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Pds Plus Antibacterial Suture.

Pre-market Notification Details

• Device ID: K061037
• 510k Number: K061037
• Device Name: PDS PLUS ANTIBACTERIAL SUTURE
• Classification: Suture, Surgical, Absorbable, Polydioxanone
• Applicant: ETHICON, INC. ROUTE 22 WEST P.O.BOX 151 Somerville, NJ 08876
• Contact: Byran A Lisa
• Correspondent: Byran A Lisa; ETHICON, INC. ROUTE 22 WEST P.O.BOX 151 Somerville, NJ 08876
• Product Code: NEW
• CFR Regulation Number: 878.4840 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2006-04-14
• Decision Date: 2006-07-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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