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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Computers And Software For Ophthalmic Use
510(k) Number K922590
Device Name BIO-PEN SRK II CALCULATOR
Applicant
Bio-Rad
635 W. Colorado St.
Glendale,  CA  91204
Applicant Contact RICHARD TEASDALE
Correspondent
Bio-Rad
635 W. Colorado St.
Glendale,  CA  91204
Correspondent Contact RICHARD TEASDALE
Classification Product Code
LQB  
Date Received06/02/1992
Decision Date 08/03/1993
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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