The following data is part of a premarket notification filed by Denver Biomedical, Inc. with the FDA for Modification To Pleurx Pleural Catheter And Drainage Kits.
| Device ID | K011831 |
| 510k Number | K011831 |
| Device Name: | MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS |
| Classification | Apparatus, Suction, Patient Care |
| Applicant | DENVER BIOMEDICAL, INC. 14998 WEST 6TH AVE., BLDG.E700 Golden, CO 80401 |
| Contact | Bonnie Vivian |
| Correspondent | Bonnie Vivian DENVER BIOMEDICAL, INC. 14998 WEST 6TH AVE., BLDG.E700 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 | 2001-06-12 |
| Decision Date | 2001-06-28 |
| Summary: | summary |