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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Air, Portable
510(k) Number K883132
Device Name NEBULIZER PUMP POWERED MODELS 020 AND 050
Applicant
Travelneb, Inc.
2925 S. Tejon
Englewood,  CO  80110
Applicant Contact ANDRE VOGLER
Correspondent
Travelneb, Inc.
2925 S. Tejon
Englewood,  CO  80110
Correspondent Contact ANDRE VOGLER
Regulation Number868.6250
Classification Product Code
BTI  
Date Received07/26/1988
Decision Date 10/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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