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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 K220288
Device Name NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector
Applicant
Np Medical, Inc.
101 Union St.
Clinton,  MA  01510
Applicant Contact Krishna Govindarajan
Correspondent
Np Medical, Inc.
101 Union St.
Clinton,  MA  01510
Correspondent Contact Krishna Govindarajan
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/01/2022
Decision Date 04/19/2023
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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