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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 K102719
Device Name ATLANTEAN TRIGGER NEBULIZER
Applicant
ATLANTEAN CORPORATION
29201 VIA NORTE
TEMECULA,  CA  92591
Applicant Contact TOM SHANKS
Correspondent
ATLANTEAN CORPORATION
29201 VIA NORTE
TEMECULA,  CA  92591
Correspondent Contact TOM SHANKS
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/21/2010
Decision Date 07/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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