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NIH — Disinfectant, Subsystem, Water Purification Class II

FDA Device Classification

Classification Details

Product Code: NIH
Device Class: Class II
Regulation Number: 876.5665
Submission Type
Review Panel: HO
Medical Specialty: Gastroenterology, Urology
Implant: No

Definition

Disinfectant intended for reprocessing water purification systems for hemodialysis.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K133724	medivators	MINNCARE HD	August 27, 2014