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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Refractometer, Ophthalmic
510(k) Number K951179
Device Name DIGITAL RETINOSCOPIC PHOTOMETER
Applicant
Kudi Kalu, Inc.
310 Clinton Ave. W.
Huntsville,  AL  35801
Applicant Contact S. H HAY
Correspondent
Kudi Kalu, Inc.
310 Clinton Ave. W.
Huntsville,  AL  35801
Correspondent Contact S. H HAY
Regulation Number886.1760
Classification Product Code
HKO  
Subsequent Product Code
HKI  
Date Received03/16/1995
Decision Date 05/30/1995
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
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