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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
510(k) Number K080712
Device Name SERIM HISENSE ULTRA 0.1, PART NUMBER 5167
Applicant
Serim Research Corp.
23565 Reedy Dr.
Elkhart,  IN  46514
Applicant Contact PATRICIA RUPCHOCK
Correspondent
Serim Research Corp.
23565 Reedy Dr.
Elkhart,  IN  46514
Correspondent Contact PATRICIA RUPCHOCK
Regulation Number876.5665
Classification Product Code
MSY  
Date Received03/13/2008
Decision Date 05/06/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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