The following data is part of a premarket notification filed by Phoenix Bioengineering, Inc. with the FDA for Sexton Cystotomy Urine Pump (scup2).
| Device ID | K904434 |
| 510k Number | K904434 |
| Device Name: | SEXTON CYSTOTOMY URINE PUMP (SCUP2) |
| Classification | Catheter, Suprapubic (and Accessories) |
| Applicant | PHOENIX BIOENGINEERING, INC. THIRD AND MILL STREETS P.O. BOX 96 Bridgeport, PA 19405 |
| Contact | Wilmer |
| Correspondent | Wilmer PHOENIX BIOENGINEERING, INC. THIRD AND MILL STREETS P.O. BOX 96 Bridgeport, PA 19405 |
| Product Code | KOB |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-28 |
| Decision Date | 1991-02-01 |