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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 K051305
Device Name CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5
Applicant
Cs Medical, LLC
3248 Lake Woodard Dr.
Raleigh,  NC  27604
Applicant Contact BEN CHEMELLI
Correspondent
Cs Medical, LLC
3248 Lake Woodard Dr.
Raleigh,  NC  27604
Correspondent Contact BEN CHEMELLI
Regulation Number892.1570
Classification Product Code
PSW  
Date Received05/19/2005
Decision Date 08/18/2005
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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