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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 K251447
Device Name K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
Applicant
Terumo Europe N.V.
Interleuvenlaan 40
Leuven,  BE 3001
Applicant Contact Liesbeth Decoster
Correspondent
Terumo Europe N.V.
Interleuvenlaan 40
Leuven,  BE 3001
Correspondent Contact Liesbeth Decoster
Regulation Number880.5570
Classification Product Code
FMI  
Date Received05/09/2025
Decision Date 07/08/2025
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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