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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 K130023
Device Name K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR
Applicant
NP MEDICAL, INC.
PO BOX 506
SOUTH LYON,  MI  48178
Applicant Contact ROBERT J BARD, JD, RAC, CQE
Correspondent
NP MEDICAL, INC.
PO BOX 506
SOUTH LYON,  MI  48178
Correspondent Contact ROBERT J BARD, JD, RAC, CQE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/03/2013
Decision Date 04/03/2013
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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