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510(k) K111740

AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION by Ameriwater — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2011
Date Received
June 21, 2011
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

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

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