The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Cook Tissue Morcellator.
Device ID | K910939 |
510k Number | K910939 |
Device Name: | COOK TISSUE MORCELLATOR |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
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 | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-06 |
Decision Date | 1991-06-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
COOK TISSUE MORCELLATOR 74268461 1818429 Dead/Cancelled |
Cook Incorporated 1992-04-23 |