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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Device, Medical Examination, Ac Powered
510(k) Number K861289
Device Name BASIC LIGHT
Applicant
Burton Medical Products Corp.
7922 Haskell Ave.
Van Nuys,  CA  91406
Applicant Contact TIM BOATMAN
Correspondent
Burton Medical Products Corp.
7922 Haskell Ave.
Van Nuys,  CA  91406
Correspondent Contact TIM BOATMAN
Regulation Number880.6320
Classification Product Code
KZF  
Date Received04/07/1986
Decision Date 04/18/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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