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FDA 510(k) Application Details - K182582
Device Classification Name
System, Delivery, Allergen And Vaccine
More FDA Info for this Device
510(K) Number
K182582
Device Name
System, Delivery, Allergen And Vaccine
Applicant
Allergy & Applicator Depot, LLC
9 Shore Drive
Sound Beach, NY 11789 US
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Contact
Steve Tramontano
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
09/19/2018
Decision Date
04/10/2019
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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