The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Ureteral Catheter.
Device ID | K923729 |
510k Number | K923729 |
Device Name: | URETERAL CATHETER |
Classification | Catheter, Ureteral, Gastro-urology |
Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
Contact | Tammy Bacon |
Correspondent | Tammy Bacon COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
Product Code | EYB |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-27 |
Decision Date | 1993-12-07 |