Device Classification Name implant, eye valve
510(k) Number K885125
Device Name KRUPIN EYE VALVE W/SCLERAL BUCKLE
Applicant
HOOD LABORATORIES
575 WASHINGTON ST.
pembroke,  MA  02359
Applicant Contact lewis h marten
Correspondent
HOOD LABORATORIES
575 WASHINGTON ST.
pembroke,  MA  02359
Correspondent Contact lewis h marten
Regulation Number886.3920
Classification Product Code
KYF  
Date Received12/12/1988
Decision Date 01/24/1989
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No