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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 K952893
Device Name THE SWIRLER AEROSOL SYSTEM
Applicant
Amici, Inc.
518 Vincent St.
Spring City,  PA  19475
Applicant Contact MICHAEL BONO
Correspondent
Amici, Inc.
518 Vincent St.
Spring City,  PA  19475
Correspondent Contact MICHAEL BONO
Regulation Number868.5630
Classification Product Code
CAF  
Date Received06/23/1995
Decision Date 11/03/1995
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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