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510(k) K093608

GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H by Gambro Renal Products, Inc. — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2010
Date Received
November 20, 2009
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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