Device Classification Name |
Implant, Eye Valve
|
510(k) Number |
K905703 |
Device Name |
KRUPIN EYE VALVE WITH DISK |
Applicant |
HOOD LABORATORIES |
575 WASHINGTON ST. |
PEMBROKE,
MA
02359
|
|
Applicant Contact |
LEWIS G MARTEN |
Correspondent |
HOOD LABORATORIES |
575 WASHINGTON ST. |
PEMBROKE,
MA
02359
|
|
Correspondent Contact |
LEWIS G MARTEN |
Regulation Number | 886.3920
|
Classification Product Code |
|
Date Received | 12/20/1990 |
Decision Date | 03/15/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|