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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 K032799
Device Name NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER
Applicant
Reichert, Inc.
3374 Walden Ave.
Depew,  NY  14043
Applicant Contact FRANK DREXELIUS
Correspondent
Reichert, Inc.
3374 Walden Ave.
Depew,  NY  14043
Correspondent Contact FRANK DREXELIUS
Regulation Number886.1930
Classification Product Code
HKX  
Date Received09/09/2003
Decision Date 01/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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