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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 K923024
Device Name NE-U04/NE U04F
Applicant
OMRON HEALTHCARE, INC.
300 LAKEVIEW PKWY.
VERNON HILLS,  IL  60061
Applicant Contact TERRENCE M O'BRIEN
Correspondent
OMRON HEALTHCARE, INC.
300 LAKEVIEW PKWY.
VERNON HILLS,  IL  60061
Correspondent Contact TERRENCE M O'BRIEN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received06/23/1992
Decision Date 09/15/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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