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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tonometer, ac-powered
510(k) Number K081756
Device Name OCULAR RESPONSE ANALYZER
Applicant
REICHERT INC.
3362 WALDEN AVE.
DEPEW,  NY  14043
Applicant Contact SANDRA BROWN
Correspondent
REICHERT INC.
3362 WALDEN AVE.
DEPEW,  NY  14043
Correspondent Contact SANDRA BROWN
Regulation Number886.1930
Classification Product Code
HKX  
Date Received06/20/2008
Decision Date 08/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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