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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Dialysate Delivery, Central Multiple Patient
510(k) Number K822535
Device Name CIDEX*DIALYZER DISINFECTING SOLUTION
Applicant
Surgikos, Inc.
Fort Worth,  TX 
Correspondent
Surgikos, Inc.
Fort Worth,  TX 
Regulation Number876.5820
Classification Product Code
FKQ  
Date Received08/24/1982
Decision Date 09/30/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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