FDA 510(k) Application Details - K051305

Device Classification Name

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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 US
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Contact BEN CHEMELLI
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Regulation Number

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Classification Product Code PSW
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Date Received 05/19/2005
Decision Date 08/18/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K051305


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