The following data is part of a premarket notification filed by Deschutes Medical Products, Inc. with the FDA for Peripump.
| Device ID | K934552 |
| 510k Number | K934552 |
| Device Name: | PERIPUMP |
| Classification | Perineometer |
| Applicant | DESCHUTES MEDICAL PRODUCTS, INC. P.O. BOX 627 Bend, OR 97709 |
| Contact | Matthew W Hoskins |
| Correspondent | Matthew W Hoskins DESCHUTES MEDICAL PRODUCTS, INC. P.O. BOX 627 Bend, OR 97709 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-21 |
| Decision Date | 1995-08-09 |