FDA 510(k) Application Details - K182582

Device Classification Name	More FDA Info for this Device
510(K) Number	K182582
Device Name	Oryum and Ovem Epidermal Deri Prick Test Applicator
Applicant	Allergy & Applicator Depot, LLC 9 Shore Drive Sound Beach, NY 11789 US Other 510(k) Applications for this Company
Contact	Steve Tramontano Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SCL 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	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review