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510(k) K150381

AQUA CLEANSE by Quality Medical Supply, Inc. — Product Code KPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2015
Date Received
February 18, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colonic Irrigation System
Device Class
Class II
Regulation Number
876.5220
Review Panel
GU
Submission Type

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