The following data is part of a premarket notification filed by Frontier Products with the FDA for Unicuff.
Device ID | K812639 |
510k Number | K812639 |
Device Name: | UNICUFF |
Classification | Transducer, Vessel Occlusion |
Applicant | FRONTIER PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXP |
CFR Regulation Number | 870.2890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-09-16 |
Decision Date | 1981-10-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
UNICUFF 75586521 not registered Dead/Abandoned |
Drypers Corporation 1998-11-09 |