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FDA 510(k) Application Details - K170585
Device Classification Name
Unit, Neonatal Phototherapy
More FDA Info for this Device
510(K) Number
K170585
Device Name
Unit, Neonatal Phototherapy
Applicant
NeoLight, LLC
1475 N Scottsdale Rd, Suite 200
Scottsdale, AZ 85257 US
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Contact
Sivakumar Palaniswamy
Other 510(k) Applications for this Contact
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
02/28/2017
Decision Date
10/27/2017
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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