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 Number886.3920
Classification Product Code
KYF  
Date Received12/20/1990
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