Device Classification Name |
Electrode, Electrosurgical, Active, Urological
|
510(k) Number |
K943879 |
Device Name |
RESECTOSCOPE ELECTRO CAUTERY CUTTING LOOP |
Applicant |
AMERICAN UROLOGICALS, INC. |
P.O. BOX 591137 |
SAN FRANCISCO,
CA
94159
|
|
Applicant Contact |
PERINCHERY NARAYAN |
Correspondent |
AMERICAN UROLOGICALS, INC. |
P.O. BOX 591137 |
SAN FRANCISCO,
CA
94159
|
|
Correspondent Contact |
PERINCHERY NARAYAN |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 08/09/1994 |
Decision Date | 02/07/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|