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510(k) K133724

MINNCARE HD by Medivators, Inc. — Product Code NIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2014
Date Received
December 6, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Disinfectant, Subsystem, Water Purification
Device Class
Class II
Regulation Number
876.5665
Review Panel
HO
Submission Type

Disinfectant intended for reprocessing water purification systems for hemodialysis.

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