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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name camera, ophthalmic, ac-powered
510(k) Number K874355
Device Name OPACITY LENSMETER 701
Applicant
INTRAOPTICS, INC.
P.O. BOX 317
HUNTINGTON,  WV  25708
Applicant Contact ELAINE GRISHABER
Correspondent
INTRAOPTICS, INC.
P.O. BOX 317
HUNTINGTON,  WV  25708
Correspondent Contact ELAINE GRISHABER
Regulation Number886.1120
Classification Product Code
HKI  
Date Received10/23/1987
Decision Date 01/26/1988
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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