Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K930572 |
Device Name |
NEZHAT-DORSEY HYDRO-DISSECTION SYSTEM II PUMP |
Applicant |
AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC. |
430 COMMERCE DR. |
DELRAY BEACH,
FL
33445
|
|
Applicant Contact |
DORSEY III |
Correspondent |
AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC. |
430 COMMERCE DR. |
DELRAY BEACH,
FL
33445
|
|
Correspondent Contact |
DORSEY III |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/04/1993 |
Decision Date | 07/23/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|