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510(k) K080712

SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 by Serim Research Corp. — Product Code MSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2008
Date Received
March 13, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Device Class
Class II
Regulation Number
876.5665
Review Panel
GU
Submission Type

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