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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Incubator, Neonatal
510(k) Number K890476
Device Name ADEL - MODEL 986 INFANT WARMER
Applicant
Adel Medical , Ltd.
16700 SE 120th Ave.
P.O. Box 542
Clackamas,  OR  97015
Applicant Contact JACKSON MCCHORD
Correspondent
Adel Medical , Ltd.
16700 SE 120th Ave.
P.O. Box 542
Clackamas,  OR  97015
Correspondent Contact JACKSON MCCHORD
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received01/31/1989
Decision Date 06/16/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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