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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name midline catheter
510(k) Number K171483
Device Name ArchFlo CT Midline
Applicant
Medcomp (dba Medical Components, Inc.)
1499 Delp Drive
Harleysville,  PA  19438
Applicant Contact Courtney Nix
Correspondent
Medcomp (dba Medical Components, Inc.)
1499 Delp Drive
Harleysville,  PA  19438
Correspondent Contact Courtney Nix
Regulation Number880.5200
Classification Product Code
PND  
Subsequent Product Code
LJS  
Date Received05/22/2017
Decision Date 12/15/2017
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
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