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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name closed antineoplastic and hazardous drug reconstitution and transfer system
510(k) Number K131549
Device Name CHEMOLOCK, CHEMOLOCK PORT
Applicant
ICU MEDICAL INC
4455 ATHERTON DRIVE
SALT LAKE CITY,  UT  84123
Applicant Contact KATHERINE KENNER
Correspondent
ICU MEDICAL INC
4455 ATHERTON DRIVE
SALT LAKE CITY,  UT  84123
Correspondent Contact KATHERINE KENNER
Regulation Number880.5440
Classification Product Code
ONB  
Subsequent Product Code
FPA  
Date Received05/29/2013
Decision Date 07/26/2013
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
Recalls CDRH Recalls
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