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510(k) K151637

UPT Series Medical RO Water System by Specialty Water Technologies — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2015
Date Received
June 17, 2015
Clearance Type
Traditional
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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