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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Infant Radiant
510(k) Number K935609
Device Name 4002 INFANT SCALE FOR INCUBATORS AND WARMERS
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 Number880.5130
Classification Product Code
FMT  
Date Received11/19/1993
Decision Date 07/01/1994
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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