The following data is part of a premarket notification filed by Purgo Biologics Inc. with the FDA for Biotex.
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() BIOTEX 90976585 not registered Live/Pending |
Premier Dental Products Company 2020-09-08 |
![]() BIOTEX 90166159 not registered Live/Pending |
Premier Dental Products Company 2020-09-08 |
![]() BIOTEX 88839169 not registered Live/Pending |
Sysco Guest Supply, LLC 2020-03-18 |
![]() BIOTEX 88839163 not registered Live/Pending |
Sysco Guest Supply, LLC 2020-03-18 |
![]() BIOTEX 85386244 4234971 Dead/Cancelled |
Progressive Wound Care Technologies, LLC 2011-08-01 |
![]() BIOTEX 79242050 not registered Live/Pending |
KANG, Ho Chang 2018-07-23 |
![]() BIOTEX 77753877 not registered Dead/Abandoned |
Crossfield Products Corporation 2009-06-07 |
![]() BIOTEX 76010433 not registered Dead/Abandoned |
Societe Anonyme Suprarev 2000-03-27 |
![]() BIOTEX 74510696 1973315 Live/Registered |
LEVY, NATALIE 1994-04-11 |
![]() BIOTEX 74301452 not registered Dead/Abandoned |
INTERMA Textilproduktions- und Handels GmbH 1992-08-04 |
![]() BIOTEX 74301451 not registered Dead/Abandoned |
INTERMA Textilproduktions- und Handels GmbH 1992-08-04 |
![]() BIOTEX 74138062 not registered Dead/Abandoned |
KORTMAN INTRADAL B.V. 1991-02-11 |