The following data is part of a premarket notification filed by Deschutes Medical Products, Inc. with the FDA for Pelvx Donut, Pelvx Cube.
| Device ID | K974117 |
| 510k Number | K974117 |
| Device Name: | PELVX DONUT, PELVX CUBE |
| Classification | Pessary, Vaginal |
| Applicant | DESCHUTES MEDICAL PRODUCTS, INC. 1011 S.W. EMKAY DR., SUITE 104 Bend, OR 97702 |
| Contact | Matthew W Hoskins |
| Correspondent | Matthew W Hoskins DESCHUTES MEDICAL PRODUCTS, INC. 1011 S.W. EMKAY DR., SUITE 104 Bend, OR 97702 |
| Product Code | HHW |
| CFR Regulation Number | 884.3575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-31 |
| Decision Date | 1998-04-27 |