The following data is part of a premarket notification filed by Denver Biomaterials, Inc. with the FDA for Denver Pleurx Pleural Catheter Kit, Catalog No. 50-7000, Denver Pleurx Home Drainage Kit, Catalog No. 50-7500.
| Device ID | K971753 |
| 510k Number | K971753 |
| Device Name: | DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500 |
| Classification | Apparatus, Suction, Patient Care |
| Applicant | DENVER BIOMATERIALS, INC. 14998 W. 6TH AVE. BLDG. E700 Golden, CO 80401 |
| Contact | Lynne Leonard |
| Correspondent | Lynne Leonard DENVER BIOMATERIALS, INC. 14998 W. 6TH AVE. BLDG. E700 Golden, CO 80401 |
| Product Code | DWM |
| CFR Regulation Number | 870.5050 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-12 |
| Decision Date | 1997-06-27 |
| Summary: | summary |