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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 K003022
Device Name AERONEB PORTABLE NEBULIZER
Applicant
AEROGEN, INC.
1310 Orleans Dr.
Sunnyvale,  CA  94089
Applicant Contact TRACI V.A. EDWARDS
Correspondent
TUV PRODUCT SERVICE, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/28/2000
Decision Date 10/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party Yes
Combination Product Yes
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