POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE

Suture, Surgical, Absorbable, Polydioxanone

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 Polydioxanone Synthetic Absorbable Surgical Suture.

Pre-market Notification Details

• Device ID: K041048
• 510k Number: K041048
• Device Name: POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE
• Classification: Suture, Surgical, Absorbable, Polydioxanone
• Applicant: INTERNACIONAL FARMACEUTICA, S.A. DE C.V. 55 Northern Blvd. Suite 200 Great Neck, NY 11021
• Contact: Carolann Kotula
• Correspondent: Carolann Kotula; INTERNACIONAL FARMACEUTICA, S.A. DE C.V. 55 Northern Blvd. Suite 200 Great Neck, NY 11021
• Product Code: NEW
• CFR Regulation Number: 878.4840 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-04-22
• Decision Date: 2004-06-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07500142161728	K041048	000
07500142109980	K041048	000
07500142110047	K041048	000
07500142110054	K041048	000
07500142110115	K041048	000
07500142115028	K041048	000
07500142116797	K041048	000
07500142116803	K041048	000
07500142117145	K041048	000
07500142117152	K041048	000
07500142017384	K041048	000
07500142117404	K041048	000
07500142118425	K041048	000
07500142118432	K041048	000
07500142119392	K041048	000
07500142119439	K041048	000
07500142124235	K041048	000
07500142109973	K041048	000
07500142109966	K041048	000
07500142105807	K041048	000
07500142110023	K041048	000
07500142116810	K041048	000
07500142117640	K041048	000
07500142154249	K041048	000
07500142159954	K041048	000
07500142165269	K041048	000
07500142002700	K041048	000
17500142002700	K041048	000
07500142104732	K041048	000
07500142105180	K041048	000
07500142105203	K041048	000
07500142105449	K041048	000
07500142105456	K041048	000
07500142105760	K041048	000
07500142105777	K041048	000
07500142105784	K041048	000
07500142129797	K041048	000
07500142129803	K041048	000
07500142129810	K041048	000
07500142166235	K041048	000
07500142179693	K041048	000
07500142179761	K041048	000
07500142179839	K041048	000
07500142179938	K041048	000
07500142180002	K041048	000
07500142180132	K041048	000
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07500142166044	K041048	000
07500142165887	K041048	000
07500142156922	K041048	000
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07500142135248	K041048	000
07500142135262	K041048	000
07500142135323	K041048	000
07500142135330	K041048	000
07500142136160	K041048	000
07500142137280	K041048	000
07500142145490	K041048	000
07500142146657	K041048	000
07500142153013	K041048	000
07500142155581	K041048	000
07500142155604	K041048	000
07500142156854	K041048	000
07500142156908	K041048	000
07500142180705	K041048	000