The following data is part of a premarket notification filed by Denver Biomedicals, Inc. with the FDA for Denver Pleurx Drainage Kit And Denver Pleurx Vacuum Bottle With Drainage Line.
| Device ID | K051084 |
| 510k Number | K051084 |
| Device Name: | DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE |
| Classification | Apparatus, Suction, Patient Care |
| Applicant | DENVER BIOMEDICALS, INC. 433 PARK POINT DRIVE, SUITE 14 Golden, CO 80401 |
| Contact | Nancy Sauer |
| Correspondent | Nancy Sauer DENVER BIOMEDICALS, INC. 433 PARK POINT DRIVE, SUITE 14 Golden, CO 80401 |
| Product Code | DWM |
| CFR Regulation Number | 870.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-28 |
| Decision Date | 2005-06-13 |
| Summary: | summary |