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
08800039003308	K180992	000
08800039000475	K180992	000
08800039000468	K180992	000
08800039000451	K180992	000
08800039000444	K180992	000
08800039000437	K180992	000
08800039000420	K180992	000
08800039000413	K180992	000
08800039000406	K180992	000
08800039000390	K180992	000
08800039000383	K180992	000
08800039000376	K180992	000
08800039000369	K180992	000
08800039000352	K180992	000
08800039000482	K180992	000
08800039000499	K180992	000
08800039003292	K180992	000
08800039003285	K180992	000
08800039003278	K180992	000
08800039003261	K180992	000
08800039000581	K180992	000
08800039000574	K180992	000
08800039000567	K180992	000
08800039000550	K180992	000
08800039000543	K180992	000
08800039000536	K180992	000
08800039000529	K180992	000
08800039000512	K180992	000
08800039000505	K180992	000
08800039000345	K180992	000