FDA 510(k) Application Details - K952803

Device Classification Name Warmer, Infant Radiant

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510(K) Number K952803
Device Name Warmer, Infant Radiant
Applicant CONTOUR MEDICAL TECHNOLOGY, INC.
144 SOUTHWAY BLVD.
P.O. BOX 397
LAVERGNE, TN 37086 US
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Contact R. KEITH FERRARI
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Regulation Number 880.5130

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Classification Product Code FMT
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Date Received 06/19/1995
Decision Date 04/04/1996
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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