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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K112564
Device Name QUIXIE NEBULIZER
Applicant
Odyssey Medical Technologies
4807 El Camino Ave.,
Suite C
Carmichael,  CA  95608
Applicant Contact DAVID PIPER
Correspondent
Odyssey Medical Technologies
4807 El Camino Ave.,
Suite C
Carmichael,  CA  95608
Correspondent Contact DAVID PIPER
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/02/2011
Decision Date 11/23/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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