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510(k) K100104

HYBERNITE RAINOUT CONTROL SYSTEM by Plastiflex Group NV — Product Code BZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2010
Date Received
January 13, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Device Class
Class II
Regulation Number
868.5270
Review Panel
AN
Submission Type

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