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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 K182891
Device Name TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants
Applicant
Cs Medical, LLC
2179 E. Lyon Station Rd.
Creedmoor,  NC  27522
Applicant Contact Kendall Ashe
Correspondent
Cs Medical, LLC
2179 E. Lyon Station Rd.
Creedmoor,  NC  27522
Correspondent Contact Kendall Ashe
Regulation Number892.1570
Classification Product Code
PSW  
Date Received10/15/2018
Decision Date 04/12/2019
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
Predetermined Change
Control Plan Authorized		 No
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