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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
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