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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 K221518
Device Name NP Medical nCompass Extension Set with Stabilizing Base
Applicant
NP Medical
101 Union Street
Clinton,  MA  01510
Applicant Contact Krishna Govindarajan
Correspondent
NP Medical
101 Union Street
Clinton,  MA  01510
Correspondent Contact Krishna Govindarajan
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/25/2022
Decision Date 11/03/2022
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
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