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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Coring (Huber) Needle
510(k) Number K162271
Device Name Pro-Lock CT Safety Infusion Set
Applicant
Medcomp (Medical Components, Inc.)
1499 Delp Dr.
Harleysville,  PA  19438
Applicant Contact COURTNEY NIX
Correspondent
Medcomp (Medical Components, Inc.)
1499 Delp Dr.
Harleysville,  PA  19438
Correspondent Contact COURTNEY NIX
Regulation Number880.5570
Classification Product Code
PTI  
Date Received08/12/2016
Decision Date 04/26/2017
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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