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 |