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FDA 510(k) Application Details - K172062
Device Classification Name
System, Delivery, Allergen And Vaccine
More FDA Info for this Device
510(K) Number
K172062
Device Name
System, Delivery, Allergen And Vaccine
Applicant
MedScience Science Research Group, Inc.
16469 Bridlewood Circle
Delray Beach, FL 33445 US
Other 510(k) Applications for this Company
Contact
Marvin Smollar
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
07/07/2017
Decision Date
03/05/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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