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510(k) K991519

AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS by Ameriwater — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2000
Date Received
April 30, 1999
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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