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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 K961843
Device Name GENIE
Applicant
BURTON MEDICAL PRODUCTS CORP.
21100 LASSEN ST.
CHATSWORTH,  CA  91311
Applicant Contact GRETEL LUMLEY
Correspondent
BURTON MEDICAL PRODUCTS CORP.
21100 LASSEN ST.
CHATSWORTH,  CA  91311
Correspondent Contact GRETEL LUMLEY
Regulation Number878.4580
Classification Product Code
FSY  
Date Received05/13/1996
Decision Date 08/22/1996
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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