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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holding Chambers, Direct Patient Interface
510(k) Number K101136
Device Name FISIO CHAMBER SPACE
Applicant
KOO(SHANGHAI)INDUSTRIES CO., LTD.
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
KOO(SHANGHAI)INDUSTRIES CO., LTD.
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number868.5630
Classification Product Code
NVP  
Date Received04/22/2010
Decision Date 01/28/2011
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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