Device Classification Name |
clamp, penile
|
510(k) Number |
K952841 |
Device Name |
THE ASSISTANT |
Applicant |
APPLE MEDICAL CORP. |
580 MAIN ST. |
BOLTON,
MA
01740
|
|
Applicant Contact |
SCOTT E COLERIDGE |
Correspondent |
APPLE MEDICAL CORP. |
580 MAIN ST. |
BOLTON,
MA
01740
|
|
Correspondent Contact |
SCOTT E COLERIDGE |
Regulation Number | 876.5160
|
Classification Product Code |
|
Date Received | 06/21/1995 |
Decision Date | 08/18/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|