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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name high level disinfection reprocessing instrument for ultrasonic transducers, liquid
510(k) Number K160921
Device Name CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant
Applicant
CS Medical LLC
2179 East Lyon Station Road
creedmoor,  NC  27522
Applicant Contact kendall ashe
Correspondent
CS Medical LLC
2179 East Lyon Station Road
creedmoor,  NC  27522
Correspondent Contact kendall ashe
Regulation Number892.1570
Classification Product Code
PSW  
Date Received04/04/2016
Decision Date 11/03/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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