Biotex

Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Purgo Biologics Inc.

The following data is part of a premarket notification filed by Purgo Biologics Inc. with the FDA for Biotex.

Pre-market Notification Details

• Device ID: K180992
• 510k Number: K180992
• Device Name: Biotex
• Classification: Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
• Applicant: Purgo Biologics Inc. E-607, 700, Pangyo-ro Bundang-gu Seongnam-si, KR 13516
• Contact: Seonghwan Song
• Correspondent: Seonghwan Song; Purgo Biologics Inc. E-607, 700, Pangyo-ro Bundang-gu Seongnam-si, KR 13516
• Product Code: NBY
• CFR Regulation Number: 878.5035 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-04-16
• Decision Date: 2019-07-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08800039006354	K180992	000
08800039006514	K180992	000
08800039006521	K180992	000
08800039006538	K180992	000
08800039006545	K180992	000
08800039006552	K180992	000
08800039006569	K180992	000
08800039006576	K180992	000
08800039006583	K180992	000
08800039006590	K180992	000
08800039006606	K180992	000
08800039006613	K180992	000
08800039006620	K180992	000
08800039006637	K180992	000
08800039006507	K180992	000
08800039006491	K180992	000
08800039006361	K180992	000
08800039006378	K180992	000
08800039006385	K180992	000
08800039006392	K180992	000
08800039006408	K180992	000
08800039006415	K180992	000
08800039006422	K180992	000
08800039006439	K180992	000
08800039006446	K180992	000
08800039006453	K180992	000
08800039006460	K180992	000
08800039006477	K180992	000
08800039006484	K180992	000
08800039006644	K180992	000
08800039000345	K180992	000
08800039000505	K180992	000
08800039000512	K180992	000
08800039000529	K180992	000
08800039000536	K180992	000
08800039000543	K180992	000
08800039000550	K180992	000
08800039000567	K180992	000
08800039000574	K180992	000
08800039000581	K180992	000
08800039003261	K180992	000
08800039003278	K180992	000
08800039003285	K180992	000
08800039003292	K180992	000
08800039000499	K180992	000
08800039000482	K180992	000
08800039000352	K180992	000
08800039000369	K180992	000
08800039000376	K180992	000
08800039000383	K180992	000
08800039000390	K180992	000
08800039000406	K180992	000
08800039000413	K180992	000
08800039000420	K180992	000
08800039000437	K180992	000
08800039000444	K180992	000
08800039000451	K180992	000
08800039000468	K180992	000
08800039000475	K180992	000
08800039003308	K180992	000