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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 K140799
FOIA Releasable 510(k) K140799
Device Name CELERITY SYSYEM
Applicant
Medcomp (Medical Components, Inc.)
25 Forest Dr.
Marlborough,  MA  01752
Applicant Contact Lorraine M Hanley
Correspondent
Medcomp (Medical Components, Inc.)
25 Forest Dr.
Marlborough,  MA  01752
Correspondent Contact Lorraine M Hanley
Regulation Number880.5970
Classification Product Code
LJS  
Date Received03/31/2014
Decision Date 06/13/2014
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
Recalls CDRH Recalls
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