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FDA 510(k) Application Details - K962612
Device Classification Name
Unit, Neonatal Phototherapy
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510(K) Number
K962612
Device Name
Unit, Neonatal Phototherapy
Applicant
MEDELA, INC.
4610 PRIME PKWY.
P.O. BOX 660
MCHENRY, IL 60050-7005 US
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Contact
STEPHEN D SMITH
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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
07/03/1996
Decision Date
12/12/1996
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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