Device Classification Name |
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
|
510(k) Number |
K952070 |
Device Name |
NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS |
Applicant |
AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC. |
430 COMMERCE DR. |
DELRAY BEACH,
FL
33445
|
|
Applicant Contact |
MARTINE D SCHEIDER |
Correspondent |
AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC. |
430 COMMERCE DR. |
DELRAY BEACH,
FL
33445
|
|
Correspondent Contact |
MARTINE D SCHEIDER |
Regulation Number | 884.4160
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/02/1995 |
Decision Date | 07/26/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|