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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scale, Patient
510(k) Number K904286
Device Name SCALE-TRONIX INCUBATOR SCALE MODEL:4050/MODIFIED
Applicant
Scale-Tronix, Inc.
P.O. Box 15
Wheaton,  IL  60189
Applicant Contact E. A STANIS
Correspondent
Scale-Tronix, Inc.
P.O. Box 15
Wheaton,  IL  60189
Correspondent Contact E. A STANIS
Regulation Number880.2720
Classification Product Code
FRW  
Date Received08/29/1990
Decision Date 10/01/1990
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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