The following data is part of a premarket notification filed by Denver Biomaterials, Inc. with the FDA for Denver Paracentesis Needle(60-1200) Denver Paracentesis Needle With Drainage Line(60-1100) Denver Paracentesis Tray.
| Device ID | K960456 |
| 510k Number | K960456 |
| Device Name: | DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY |
| Classification | Kit, Surgical Instrument, Disposable |
| Applicant | DENVER BIOMATERIALS, INC. 6851 HIGHWAY 73 Evergreen, CO 80439 |
| Contact | Lynne Leonard |
| Correspondent | Lynne Leonard DENVER BIOMATERIALS, INC. 6851 HIGHWAY 73 Evergreen, CO 80439 |
| Product Code | KDD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-30 |
| Decision Date | 1996-04-01 |
| Summary: | summary |