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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K251257
Device Name nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]
Applicant
Np Medical
101 Union St.
Clinton,  MA  01510
Applicant Contact Albert Sanford
Correspondent
Np Medical
101 Union St.
Clinton,  MA  01510
Correspondent Contact Albert Sanford
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/23/2025
Decision Date 12/04/2025
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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