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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 Transport
510(k) Number K790689
Device Name REVISED BATTERY CHARGER
Applicant
Vickers America Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Vickers America Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5410
Classification Product Code
FPL  
Date Received04/10/1979
Decision Date 05/29/1979
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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