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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
Teleflex Medical, Inc.
24301 WOODSAGE DR
BONITA SPRINGS,  FL  34134 -2015
Applicant Contact PAUL DRYDEN
Correspondent
Teleflex Medical, 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
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