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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 K080230
Device Name NEB-U-MASK SYSTEM, MODELS 1895, 1896
Applicant
Teleflexmedical, Inc.
24301 Woodsage Dr.
Bonita Springs,  FL  34134 -2015
Applicant Contact PAUL DRYDEN
Correspondent
Teleflexmedical, Inc.
24301 Woodsage Dr.
Bonita Springs,  FL  34134 -2015
Correspondent Contact PAUL DRYDEN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/30/2008
Decision Date 06/09/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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