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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K140133
FOIA Releasable 510(k) K140133
Device Name INFUSET FLOW CONTROL EXTENSION SET
Applicant
Emed Technologies Corporation
1264 Hawks Flight Ct, Suite 200
El Dorado Hills,  CA  95762
Applicant Contact PETER KOLLINGS
Correspondent
Emed Technologies Corporation
1264 Hawks Flight Ct, Suite 200
El Dorado Hills,  CA  95762
Correspondent Contact PETER KOLLINGS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/17/2014
Decision Date 05/15/2014
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
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