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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, floor standing
510(k) Number K860020
Device Name MINOR SURGERY LIGHT MODEL 2112
Applicant
ADEL MEDICAL LTD.
16700 S.E. 120TH AVE.
P.O. BOX 542
CLACKAMAS,  OR  97015
Applicant Contact DAVE COLE
Correspondent
ADEL MEDICAL LTD.
16700 S.E. 120TH AVE.
P.O. BOX 542
CLACKAMAS,  OR  97015
Correspondent Contact DAVE COLE
Regulation Number878.4580
Classification Product Code
FSS  
Date Received01/03/1986
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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