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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name photostimulator, ac-powered
510(k) Number K853812
Device Name PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)
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 Number886.1630
Classification Product Code
HLX  
Date Received09/12/1985
Decision Date 11/01/1985
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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