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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 K914836
Device Name OMRON COMPRESSOR NEBULIZER- MODEL NE-C09
Applicant
Omron Healthcare, Inc.
300 Lakeview Pkwy.
Vernon Hills,  IL  60061
Applicant Contact LEE A.CABOT
Correspondent
Omron Healthcare, Inc.
300 Lakeview Pkwy.
Vernon Hills,  IL  60061
Correspondent Contact LEE A.CABOT
Regulation Number868.5630
Classification Product Code
CAF  
Date Received10/25/1991
Decision Date 05/06/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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