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510(k) K182582

Oryum and Ovem Epidermal Deri Prick Test Applicator by Allergy & Applicator Depot, LLC — Product Code SCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2019
Date Received
September 19, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Allergen And Vaccine Delivery Needles
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

An allergen delivery needle is a device intended to percutaneously deliver diagnostic allergenic extracts for use in allergy skin tests also referred to as skin prick tests or intradermal allergy tests.

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  • K020500 — UNIVEC BIFURCATED SLIDING SHEATH SYRINGE (March 19, 2002)
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