The following data is part of a premarket notification filed by Lic-orthion with the FDA for Bibag, Biband & Bifix - Single Use Urine Collector.
| Device ID | K851470 |
| 510k Number | K851470 |
| Device Name: | BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | LIC-ORTHION RODNEY R. MUNSEY 2101 L STREET N.W. Washington, DC 20037 |
| Contact | Rodney R Munsey |
| Correspondent | Rodney R Munsey LIC-ORTHION RODNEY R. MUNSEY 2101 L STREET N.W. Washington, DC 20037 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-15 |
| Decision Date | 1985-06-12 |