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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 K021175
Device Name AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000
Applicant
Aerogen, Inc.
1310 Orleans Dr.
Sunnyvale,  CA  94089
Applicant Contact TRACI V. A EDWARDS
Correspondent
Tuv America, Inc.
1775 Old Highway 8
New Brighton,  MN  55112 -1891
Correspondent Contact MARK JOB
Regulation Number868.5630
Classification Product Code
CAF  
Date Received04/12/2002
Decision Date 05/15/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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