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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 K901706
Device Name LIGHT, HEAD, EXAMINATION
Applicant
Burton Medical Products Corp.
7922 Haskell Ave.
Van Nuys,  CA  91406
Applicant Contact LANI TONNU
Correspondent
Burton Medical Products Corp.
7922 Haskell Ave.
Van Nuys,  CA  91406
Correspondent Contact LANI TONNU
Regulation Number880.6320
Classification Product Code
KZF  
Date Received04/12/1990
Decision Date 07/19/1990
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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