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 |