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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name humidifier, respiratory gas, (direct patient interface)
510(k) Number K092256
Device Name THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012
Applicant
SMITHS MEDICAL ASD, INC.
160 WEYMOUTH ST.
ROCKLAND,  MA  02370
Applicant Contact PAT MCLEISH
Correspondent
SMITHS MEDICAL ASD, INC.
160 WEYMOUTH ST.
ROCKLAND,  MA  02370
Correspondent Contact PAT MCLEISH
Regulation Number868.5450
Classification Product Code
BTT  
Subsequent Product Code
BZE  
Date Received07/28/2009
Decision Date 10/20/2010
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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