The following data is part of a premarket notification filed by Gwr Medical, Llp with the FDA for O2 Boot.
Device ID | K971507 |
510k Number | K971507 |
Device Name: | O2 BOOT |
Classification | Chamber, Oxygen, Topical, Extremity |
Applicant | GWR MEDICAL, LLP 124 COMMONS COURT Chadds Ford, PA 19317 |
Contact | Joseph R Westwood |
Correspondent | Joseph R Westwood GWR MEDICAL, LLP 124 COMMONS COURT Chadds Ford, PA 19317 |
Product Code | KPJ |
CFR Regulation Number | 878.5650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-04-25 |
Decision Date | 1997-11-07 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() O2 BOOT 76384278 2736142 Live/Registered |
GWR Medical, Inc. 2002-03-19 |
![]() O2 BOOT 75257145 not registered Dead/Abandoned |
GWR Medical Inc., L.L.P. 1997-03-14 |