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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 K062263
Device Name OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22
Applicant
OMRON HEALTHCARE, INC.
3460 POINTE CREEK COURT #102
BONITA SPRINGS,  FL  34134
Applicant Contact RANNDY KELLOGG
Correspondent
OMRON HEALTHCARE, INC.
3460 POINTE CREEK COURT #102
BONITA SPRINGS,  FL  34134
Correspondent Contact RANNDY KELLOGG
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/04/2006
Decision Date 02/23/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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