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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name light, surgical, ceiling mounted
510(k) Number K042395
Device Name OUTPATIENT III MINOR SURGERY LIGHT
Original Applicant
BURTON MEDICAL PRODUCTS CORP.
21100 lassen st.
chatsworth,  CA  91311
Original Contact asle asmul
Regulation Number878.4580
Classification Product Code
FSY  
Date Received09/02/2004
Decision Date 12/01/2004
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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