MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED

Suture, Absorbable, Synthetic

ETHICON, INC.

The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Monocryl (poliglecaprone 25) Suture, Undyed.

Pre-market Notification Details

• Device ID: K964072
• 510k Number: K964072
• Device Name: MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED
• Classification: Suture, Absorbable, Synthetic
• Applicant: ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151
• Contact: John D Paulson
• Correspondent: John D Paulson; ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151
• Product Code: GAN
• CFR Regulation Number: 878.4830 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-10-11
• Decision Date: 1996-12-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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