The following data is part of a premarket notification filed by Denver Biomaterials, Inc. with the FDA for Denver Ascites Shunts, Denver Ascites Shunt Percutaneous Access Kits.
| Device ID | K973129 |
| 510k Number | K973129 |
| Device Name: | DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS |
| Classification | Shunt, Peritoneal |
| Applicant | DENVER BIOMATERIALS, INC. 6851 HIGHWAY 73 Evergreen, CO 80439 |
| Contact | Bonnie Vivian |
| Correspondent | Bonnie Vivian DENVER BIOMATERIALS, 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 | 1997-08-21 |
| Decision Date | 1998-03-17 |
| Summary: | summary |