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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 K053360
Device Name AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C
Applicant
AEROVECTRX CORPORATION
6224 SAMOA WAY
CARMICHAEL,  CA  95608
Applicant Contact DAVE PIPER
Correspondent
AEROVECTRX CORPORATION
6224 SAMOA WAY
CARMICHAEL,  CA  95608
Correspondent Contact DAVE PIPER
Regulation Number868.5630
Classification Product Code
CAF  
Date Received12/02/2005
Decision Date 03/23/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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