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FDA 510(k) Application Details - K123184
Device Classification Name
System, Delivery, Allergen And Vaccine
More FDA Info for this Device
510(K) Number
K123184
Device Name
System, Delivery, Allergen And Vaccine
Applicant
SMART PRACTICE
3400 EAST MCDOWELL RD.
PHOENIX, AZ 85008 US
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Contact
KIM SULLIVAN
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LDH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/10/2012
Decision Date
12/19/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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