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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 K970686
Device Name ACCUTEMP-PROBE
Applicant
Kentec Medical, Inc.
17871 Fitch
Irvine,  CA  92614 -6001
Applicant Contact MATT WILKEN
Correspondent
Kentec Medical, Inc.
17871 Fitch
Irvine,  CA  92614 -6001
Correspondent Contact MATT WILKEN
Regulation Number880.5130
Classification Product Code
FMT  
Date Received02/25/1997
Decision Date 08/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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