The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Balloon (nephrostomy Tract) Dilation Catheter Set.
Device ID | K891406 |
510k Number | K891406 |
Device Name: | BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET |
Classification | Catheter, Nephrostomy |
Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
Contact | Michelle Young |
Correspondent | Michelle Young COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
Product Code | LJE |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-14 |
Decision Date | 1989-04-07 |