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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 K974379
Device Name ULTRANEB
Applicant
Bremed Italia, S.R.L.
1337 Rockwood Forest Dr.
Arnold,  MO  63010
Applicant Contact MARK HEBENSTREIT
Correspondent
Bremed Italia, S.R.L.
1337 Rockwood Forest Dr.
Arnold,  MO  63010
Correspondent Contact MARK HEBENSTREIT
Regulation Number868.5630
Classification Product Code
CAF  
Date Received11/20/1997
Decision Date 02/18/1998
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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