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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K230959
Device Name VitreJect® Needle; OcuSafe® Needle
Applicant
Ocuject, LLC
1441 Avocado Ave.
Suite 204
Newport Beach,  CA  92660
Applicant Contact Leonid Lerner
Correspondent
Namsa
400 Hwy. 169 S.
Suite 500
Minneapolis,  MN  55426
Correspondent Contact Heidi Busz
Regulation Number880.5570
Classification Product Code
FMI  
Date Received04/04/2023
Decision Date 09/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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