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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
510(k) Number K100104
Device Name HYBERNITE RAINOUT CONTROL SYSTEM
Applicant
PLASTIFLEX GROUP NV
220 RIVER ROAD
CLAREMONT,  NH  03743
Applicant Contact WILLIAM GREENROSE
Correspondent
PLASTIFLEX GROUP NV
220 RIVER ROAD
CLAREMONT,  NH  03743
Correspondent Contact WILLIAM GREENROSE
Regulation Number868.5270
Classification Product Code
BZE  
Date Received01/13/2010
Decision Date 04/14/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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