Device Classification Name |
resectoscope
|
510(k) Number |
K971881 |
Device Name |
COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS |
Applicant |
COMEG ENDOSCOPY |
13790 EAST RICE PLACE |
AURORA,
CO
80015
|
|
Applicant Contact |
KAELYN HADLEY |
Correspondent |
COMEG ENDOSCOPY |
13790 EAST RICE PLACE |
AURORA,
CO
80015
|
|
Correspondent Contact |
KAELYN HADLEY |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/20/1997 |
Decision Date | 08/12/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|