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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lamp, surgical
510(k) Number K860088
Device Name PL EXAM 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 Number878.4580
Classification Product Code
FTD  
Date Received01/10/1986
Decision Date 01/24/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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