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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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IRA LAPIDES
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Regulation Number
880.5700
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Classification Product Code
LBI
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More FDA Info for this Product Code
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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