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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 K950422
Device Name FIRST TOUCH DISPOSABLES TEMPERATURE PROBES
Applicant
First Touch Disposables, Inc.
3342 Wrightville Ave.
Wilmington,  NC  28403
Applicant Contact W. R DE VITA
Correspondent
First Touch Disposables, Inc.
3342 Wrightville Ave.
Wilmington,  NC  28403
Correspondent Contact W. R DE VITA
Regulation Number880.5130
Classification Product Code
FMT  
Date Received02/02/1995
Decision Date 01/23/1997
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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