Device Classification Name |
probe and director, gastro-urology
|
510(k) Number |
K993436 |
Device Name |
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 |
|
Subsequent Product Code |
|
Date Received | 10/12/1999 |
Decision Date | 02/11/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|