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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, long-term greater than 30 days
510(k) Number K180567
Device Name C3 Wave System
Applicant
Medical Components, Inc. (dba Medcomp)
1499 Delp Drive
Harleysville,  PA  19438
Applicant Contact Courtney Nix
Correspondent
Medical Components, Inc. (dba Medcomp)
1499 Delp Drive
Harleysville,  PA  19438
Correspondent Contact Courtney Nix
Regulation Number880.5970
Classification Product Code
LJS  
Date Received03/05/2018
Decision Date 04/12/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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