Device Classification Name |
Cystoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K982620 |
Device Name |
MEDIVISION CYSTOSCOPE |
Applicant |
MEDIVISION SCOPE SERVICE CENTER, INC. |
1440 SOUTH STATE COLLEGE BLVD. |
SUITE 1C |
ANAHEIM,
CA
92806
|
|
Applicant Contact |
WAYNE B STERNER |
Correspondent |
MEDIVISION SCOPE SERVICE CENTER, INC. |
1440 SOUTH STATE COLLEGE BLVD. |
SUITE 1C |
ANAHEIM,
CA
92806
|
|
Correspondent Contact |
WAYNE B STERNER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/27/1998 |
Decision Date | 09/30/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|