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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 K870121
Device Name DIGILAB MICRO ONE APPLANATION TONOMETER
Applicant
BIO-RAD
180 Cabot Street
Beverly,  MA  01915
Applicant Contact JOSEPH F CHALUPA
Correspondent
BIO-RAD
180 Cabot Street
Beverly,  MA  01915
Correspondent Contact JOSEPH F CHALUPA
Regulation Number886.1930
Classification Product Code
HKX  
Date Received01/12/1987
Decision Date 02/20/1987
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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