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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name headlight, fiberoptic focusing
510(k) Number K960767
Device Name LIGHT COMMANDER
Applicant
SCIERAN TECHNOLOGIES, INC.
27071 CABOT RD., SUITE 127
LAGUNA HILLS,  CA  92653
Applicant Contact ROD ROSS
Correspondent
SCIERAN TECHNOLOGIES, INC.
27071 CABOT RD., SUITE 127
LAGUNA HILLS,  CA  92653
Correspondent Contact ROD ROSS
Regulation Number886.4335
Classification Product Code
FCT  
Subsequent Product Code
FTD  
Date Received02/26/1996
Decision Date 08/26/1996
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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