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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K221974
Device Name EpiFinder
Applicant
Omeq Medical , Ltd.
17 Tchelet St. Misgav Business Park
Misgav,  IL 2017400
Applicant Contact Lior Margalit
Correspondent
Hogan Lovells US LLP
1735 Market St.
23rd Floor
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number880.5860
Classification Product Code
FMF  
Date Received07/05/2022
Decision Date 04/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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