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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmic Needle
510(k) Number K230951
Device Name Terumo Injection Filter Needle (NF-3013RBKE05M)
Applicant
Terumo Europe N.V.
Interleuvenlaan 40
Leuven,  BE 3012
Applicant Contact Liesbeth Decoster
Correspondent
Terumo Europe N.V.
Interleuvenlaan 40
Leuven,  BE 3012
Correspondent Contact Liesbeth Decoster
Regulation Number880.5570
Classification Product Code
QYM  
Date Received04/04/2023
Decision Date 10/18/2023
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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