The following data is part of a premarket notification filed by Denver Biomedicals, Inc. with the FDA for Denver Peritoneo-venous Shunt.
| Device ID | K811183 |
| 510k Number | K811183 |
| Device Name: | DENVER PERITONEO-VENOUS SHUNT |
| Classification | Shunt, Peritoneal |
| Applicant | DENVER BIOMEDICALS, INC. P.O. BOX 1128 Englewood , CO 80150 - |
| Contact | John B Newkirk |
| Correspondent | John B Newkirk DENVER BIOMEDICALS, INC. P.O. BOX 1128 Englewood , CO 80150 - |
| Product Code | KPM |
| CFR Regulation Number | 876.5955 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-29 |
| Decision Date | 1981-07-01 |