FDA 510(k) Application Details - K021531

Device Classification Name Unit, Neonatal Phototherapy

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510(K) Number K021531
Device Name Unit, Neonatal Phototherapy
Applicant REPLACEMENT PARTS INDUSTRIES, INC.
P.O. BOX 5019
CHATSWORTH, CA 91313-5019 US
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Contact IRA LAPIDES
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Regulation Number 880.5700

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Classification Product Code LBI
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Date Received 05/10/2002
Decision Date 05/31/2002
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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