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510(k) K021560

MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS by Ameriwater — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2003
Date Received
May 13, 2002
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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