ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES

Suture, Absorbable, Synthetic, Polyglycolic Acid

INTERNACIONAL FARMACEUTICA, S.A. DE C.V.

The following data is part of a premarket notification filed by Internacional Farmaceutica, S.a. De C.v. with the FDA for Atramat Pgc25 Poly(glycolide-co-epsilon-caprolactone) Surgical Sutures.

Pre-market Notification Details

• Device ID: K072863
• 510k Number: K072863
• Device Name: ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES
• Classification: Suture, Absorbable, Synthetic, Polyglycolic Acid
• Applicant: INTERNACIONAL FARMACEUTICA, S.A. DE C.V. 55 Northern Blvd. Suite 200 Great Neck, NY 11021
• Contact: Allan P Schwartz
• Correspondent: Allan P Schwartz; INTERNACIONAL FARMACEUTICA, S.A. DE C.V. 55 Northern Blvd. Suite 200 Great Neck, NY 11021
• Product Code: GAM
• CFR Regulation Number: 878.4493 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-10-05
• Decision Date: 2008-05-23
• Summary: summary

NIH GUDID Devices

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