FDA 510(k) Application Details - K200319

Device Classification Name Warmer, Infant Radiant

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510(K) Number K200319
Device Name Warmer, Infant Radiant
Applicant DeRoyal Industries, Inc.
200 DeBusk Lane
Powell, TN 37849 US
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Contact Sarah Bennett
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Regulation Number 880.5130

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Classification Product Code FMT
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Date Received 02/07/2020
Decision Date 04/02/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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