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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 SE 120th Ave.
P.O. Box 542
Clackamas,  OR  97015
Applicant Contact DAVE COLE
Correspondent
Adel Medical , Ltd.
16700 SE 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
Predetermined Change
Control Plan Authorized		 No
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