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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K193278
Device Name MedSource CathMED IV Catheter
Applicant
Medsource Labs
4201 Norex Dr.
Chaska,  MN  55318
Applicant Contact Emilie Andrews
Correspondent
Medsource Labs
4201 Norex Dr.
Chaska,  MN  55318
Correspondent Contact Emilie Andrews
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received11/27/2019
Decision Date 08/07/2020
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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