The following data is part of a premarket notification filed by Denver Biomedicals, Inc. with the FDA for The Denver Pleural-peritoneal Shunt.
| Device ID | K842139 |
| 510k Number | K842139 |
| Device Name: | THE DENVER PLEURAL-PERITONEAL SHUNT |
| Classification | Shunt, Peritoneal |
| Applicant | DENVER BIOMEDICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPM |
| CFR Regulation Number | 876.5955 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-30 |
| Decision Date | 1984-08-27 |