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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratoscope, Battery-Powered
510(k) Number K854054
Device Name PLACIDO DISC
Applicant
CUTLER MEDICAL INSTRUMENTS
4607 KENNETH AVE.
SANTA MONICA,  CA  93455
Applicant Contact DAVID P CUTLER
Correspondent
CUTLER MEDICAL INSTRUMENTS
4607 KENNETH AVE.
SANTA MONICA,  CA  93455
Correspondent Contact DAVID P CUTLER
Regulation Number886.1350
Classification Product Code
HLR  
Date Received10/03/1985
Decision Date 12/27/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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