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FDA 510(k) Application Details - K080712
Device Classification Name
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
More FDA Info for this Device
510(K) Number
K080712
Device Name
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Applicant
SERIM RESEARCH CORP.
23565 REEDY DR.
ELKHART, IN 46514 US
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Contact
PATRICIA RUPCHOCK
Other 510(k) Applications for this Contact
Regulation Number
876.5665
More FDA Info for this Regulation Number
Classification Product Code
MSY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/13/2008
Decision Date
05/06/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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