The following data is part of a premarket notification filed by Instrumed, Inc. with the FDA for Accuflate.
Device ID | K924273 |
510k Number | K924273 |
Device Name: | ACCUFLATE |
Classification | Tourniquet, Pneumatic |
Applicant | INSTRUMED, INC. 11818 N. CREEK PARKWAY NORTH SUITE 105 Bothell, WA 98011 |
Contact | Jerry L Spence |
Correspondent | Jerry L Spence INSTRUMED, INC. 11818 N. CREEK PARKWAY NORTH SUITE 105 Bothell, WA 98011 |
Product Code | KCY |
CFR Regulation Number | 878.5910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-24 |
Decision Date | 1993-01-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ACCUFLATE 86149183 4572089 Live/Registered |
Wilkerson Company, Inc 2013-12-20 |
ACCUFLATE 74109554 1717061 Dead/Cancelled |
SMITH & NEPHEW RICHARDS, INC. 1990-10-26 |
ACCUFLATE 73418087 not registered Dead/Abandoned |
R.J.STUCKEL COMPANY 1983-03-21 |
ACCUFLATE 73313925 1193012 Dead/Cancelled |
Grant Airmass Corporation 1981-06-05 |