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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K050803
Device Name PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES
Applicant
VITAID, LTD.
6329 W. WATERVIEW CT.
MCCORDSVILLE,  IN  46055 -9501
Applicant Contact PAUL E DRYDEN
Correspondent
VITAID, LTD.
6329 W. WATERVIEW CT.
MCCORDSVILLE,  IN  46055 -9501
Correspondent Contact PAUL E DRYDEN
Regulation Number868.5730
Classification Product Code
BTR  
Date Received03/30/2005
Decision Date 06/30/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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