The following data is part of a premarket notification filed by Denver Biomedicals, Inc. with the FDA for Denver(r) Peritoneo-subclavian Shunt.
| Device ID | K913728 |
| 510k Number | K913728 |
| Device Name: | DENVER(R) PERITONEO-SUBCLAVIAN SHUNT |
| Classification | Shunt, Peritoneal |
| Applicant | DENVER BIOMEDICALS, INC. 6851 HIGHWAY 73 Evergreen, CO 80439 |
| Contact | Shirley K Freeman |
| Correspondent | Shirley K Freeman DENVER BIOMEDICALS, INC. 6851 HIGHWAY 73 Evergreen, CO 80439 |
| Product Code | KPM |
| CFR Regulation Number | 876.5955 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-20 |
| Decision Date | 1994-02-18 |