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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 K893808
Device Name MODEL 0450000, OPAL MEDICAL EXAM LIGHT
Applicant
Burton Medical Products Corp.
7922 Haskell Ave.
Van Nuys,  CA  91406
Applicant Contact SWARTZ
Correspondent
Burton Medical Products Corp.
7922 Haskell Ave.
Van Nuys,  CA  91406
Correspondent Contact SWARTZ
Regulation Number880.6320
Classification Product Code
KZF  
Date Received05/22/1989
Decision Date 08/15/1989
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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