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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cap, Device Disinfectant
510(k) Number K190918
Device Name SwabTip Male Disinfectant Cap
Applicant
Icu Medical
600 N. Field Dr.
Lake Forest,  IL  60045
Applicant Contact Nichelle Cato
Correspondent
Icu Medical
600 N. Field Dr.
Lake Forest,  IL  60045
Correspondent Contact Nichelle Cato
Regulation Number880.5440
Classification Product Code
QBP  
Date Received04/09/2019
Decision Date 03/06/2020
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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