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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 K942553
Device Name GENESIS
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
FTD  
Date Received05/31/1994
Decision Date 06/23/1994
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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