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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 K123729
FOIA Releasable 510(k) K123729
Device Name VERSARATE FLOW RATE CONTROLER
Applicant
EMED TECHNOLOGIES CORPORATION
1264 Hawks Flight Ct Ste 200
EL DORADO HILLS,  CA  95762
Applicant Contact PETER KOLLINGS
Correspondent
UNDERWRITERS LABORATORIES, INC.
455 E. TRIMBLE ROAD
SAN JOSE,  CA  95131 -1230
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/05/2012
Decision Date 12/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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