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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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