IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES

Suture, Nonabsorbable, Synthetic, Polyester

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 Ifsa Sterile Braided Poly Nonabsor Surg Sutures.

Pre-market Notification Details

• Device ID: K905285
• 510k Number: K905285
• Device Name: IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES
• Classification: Suture, Nonabsorbable, Synthetic, Polyester
• 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: GAS
• CFR Regulation Number: 878.5000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-11-26
• Decision Date: 1991-02-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07500142905049	K905285	000
07500142117367	K905285	000
07500142920493	K905285	000
07500142921261	K905285	000
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07500142129841	K905285	000
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07500142163739	K905285	000
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07500142180569	K905285	000