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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 K122705
Device Name HUMICARE D900
Applicant
Grundler GmbH
9001 Spectrum Center Blvd.
San Diego,  CA  92123
Applicant Contact JIM CASSI
Correspondent
Tuv Sud America, Inc.
1775 Old Hwy. 8 NW
New Brighton,  MN  55112
Correspondent Contact OLAF TEICHERT
Regulation Number868.5450
Classification Product Code
BTT  
Date Received09/04/2012
Decision Date 05/21/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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