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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 K860205
Device Name BIO-PEN CALCULATOR
Applicant
Oculab, Inc.
443 W. Colorado St.
Gendale,  CA  91204
Applicant Contact RICHARD W TEASDALE
Correspondent
Oculab, Inc.
443 W. Colorado St.
Gendale,  CA  91204
Correspondent Contact RICHARD W TEASDALE
Classification Product Code
LQB  
Date Received01/22/1986
Decision Date 04/24/1986
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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