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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 K990506
Device Name MABIS NB-02 ULTRASONIC NEBULIZER
Applicant
Mabis Healthcare, Inc.
28690 Ballard Dr.
Lake Forest,  IL  60045
Applicant Contact STEVEN M BISULCA
Correspondent
Mabis Healthcare, Inc.
28690 Ballard Dr.
Lake Forest,  IL  60045
Correspondent Contact STEVEN M BISULCA
Regulation Number868.5630
Classification Product Code
CAF  
Date Received02/17/1999
Decision Date 03/11/1999
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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