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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 K992831
Device Name AERONEB II, MODEL APN 200
Applicant
AEROGEN, INC.
1310 Orleans Dr.
Sunnyvale,  CA  94089
Applicant Contact TRACI V. A EDWARDS
Correspondent
AEROGEN, INC.
1310 Orleans Dr.
Sunnyvale,  CA  94089
Correspondent Contact TRACI V. A EDWARDS
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/23/1999
Decision Date 08/25/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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