FDA 510(k) Application Details - K960080

Device Classification Name Warmer, Infant Radiant

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510(K) Number K960080
Device Name Warmer, Infant Radiant
Applicant KENTEC MEDICAL, INC.
17871 FITCH
IRVINE, CA 92614-6001 US
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Contact MATT WILKEN
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Regulation Number 880.5130

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Classification Product Code FMT
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Date Received 01/11/1996
Decision Date 05/01/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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