STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES

Suture, Absorbable, Natural

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 Sterile Plain Gut/chromic Gut Absorb Surg Sutures.

Pre-market Notification Details

• Device ID: K911354
• 510k Number: K911354
• Device Name: STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES
• Classification: Suture, Absorbable, Natural
• Applicant: INTERNACIONAL FARMACEUTICA, S.A. DE C.V. C/O MEDICAL DEVICE INSPECTION 55 NORTHERN BOULEVARD, STE 301 Great Neck, NY 11021
• Contact: Alan P Schwartz
• Correspondent: Alan P Schwartz; INTERNACIONAL FARMACEUTICA, S.A. DE C.V. C/O MEDICAL DEVICE INSPECTION 55 NORTHERN BOULEVARD, STE 301 Great Neck, NY 11021
• Product Code: GAL
• CFR Regulation Number: 878.4830 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-03-26
• Decision Date: 1991-10-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07500142006531	K911354	000
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07500142106774	K911354	000