Device Classification Name |
probe and director, gastro-urology
|
510(k) Number |
K010098 |
Device Name |
MODIFICATION TO CAVERMAP SURGICAL AID |
Applicant |
UROMED CORP. |
1400 PROVIDENCE HWY. |
NORWOOD,
MA
02062
|
|
Applicant Contact |
FREDERICK TOBIA |
Correspondent |
UROMED CORP. |
1400 PROVIDENCE HWY. |
NORWOOD,
MA
02062
|
|
Correspondent Contact |
FREDERICK TOBIA |
Regulation Number | 876.4730
|
Classification Product Code |
|
Date Received | 01/11/2001 |
Decision Date | 02/01/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|