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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screen, Tangent, Ac-Powered (Campimeter)
510(k) Number K860642
Device Name PHOTRON VISUAL FIELD ANALYZER
Applicant
Biosan Laboratories, Inc.
1016 C St.
San Rafael,  CA  94901
Applicant Contact JOHN DOWNING
Correspondent
Biosan Laboratories, Inc.
1016 C St.
San Rafael,  CA  94901
Correspondent Contact JOHN DOWNING
Regulation Number886.1810
Classification Product Code
HOM  
Date Received02/20/1986
Decision Date 04/15/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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