Device Classification Name |
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
|
510(k) Number |
K950499 |
Device Name |
NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS |
Applicant |
AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC. |
430 COMMERCE DR. |
DELRAY BEACH,
FL
33445
|
|
Applicant Contact |
MARTINE D SCHNEIDER |
Correspondent |
AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC. |
430 COMMERCE DR. |
DELRAY BEACH,
FL
33445
|
|
Correspondent Contact |
MARTINE D SCHNEIDER |
Regulation Number | 884.4160
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/06/1995 |
Decision Date | 06/16/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|