The following data is part of a premarket notification filed by Clinical Innovations, Inc. with the FDA for Colpo Cup Cvc-2000.
| Device ID | K974563 |
| 510k Number | K974563 |
| Device Name: | COLPO CUP CVC-2000 |
| Classification | Elevator, Uterine |
| Applicant | CLINICAL INNOVATIONS, INC. 6477 SOUTH COTTONWOOD ST. Murray, UT 84107 |
| Contact | Wm. Dean Wallace |
| Correspondent | Wm. Dean Wallace CLINICAL INNOVATIONS, INC. 6477 SOUTH COTTONWOOD ST. Murray, UT 84107 |
| Product Code | HDP |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-05 |
| Decision Date | 1998-03-02 |
| Summary: | summary |