The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Magnetic Retriever.
Device ID | K925565 |
510k Number | K925565 |
Device Name: | MAGNETIC RETRIEVER |
Classification | Laparoscope, General & Plastic Surgery |
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 | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-03 |
Decision Date | 1993-02-23 |