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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 K173477
Device Name ChemoCLAVE Cytotoxic Medication Preparation and Delivery System
Applicant
ICU Medical, Inc.
600 N. Field Drive
Lake Forest,  IL  60045
Applicant Contact Catherine E. Kang
Correspondent
ICU Medical, Inc.
600 N. Field Drive
Lake Forest,  IL  60045
Correspondent Contact Catherine E. Kang
Regulation Number880.5440
Classification Product Code
ONB  
Subsequent Product Codes
FPA   LHI  
Date Received11/13/2017
Decision Date 08/31/2018
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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