The following data is part of a premarket notification filed by Denver Biomedicals, Inc. with the FDA for Denver Pak W/ Double-valve Ascites Shunt,denver Pak W/ Single-valved Ascites Shunt, Denver Pak, Doubled-valved Ascites T.
| Device ID | K003451 |
| 510k Number | K003451 |
| Device Name: | DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T |
| Classification | Shunt, Peritoneal |
| Applicant | DENVER BIOMEDICALS, INC. 14998 W. 6TH AVE., BLDG. E700 Golden, CO 80401 |
| Contact | Bonnie Vivian |
| Correspondent | Bonnie Vivian DENVER BIOMEDICALS, INC. 14998 W. 6TH AVE., BLDG. E700 Golden, CO 80401 |
| Product Code | KPM |
| CFR Regulation Number | 876.5955 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-07 |
| Decision Date | 2001-01-02 |