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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K884619
Device Name PACH-PEN CALCULATOR
Applicant
Oculab, Inc.
443 W. Colorado St.
Gendale,  CA  91204
Applicant Contact DAVID A WALLACE
Correspondent
Oculab, Inc.
443 W. Colorado St.
Gendale,  CA  91204
Correspondent Contact DAVID A WALLACE
Regulation Number870.1435
Classification Product Code
DXG  
Date Received11/04/1988
Decision Date 02/02/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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