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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tube, tracheostomy (w/wo connector)
510(k) Number K031553
Device Name SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
Applicant
ARCADIA MEDICAL CORPORATION
962 ALLEGRO LANE
APOLLO BEACH,  FL  33572
Applicant Contact ARTHUR WARD
Correspondent
ARCADIA MEDICAL CORPORATION
962 ALLEGRO LANE
APOLLO BEACH,  FL  33572
Correspondent Contact ARTHUR WARD
Regulation Number868.5800
Classification Product Code
BTO  
Date Received05/19/2003
Decision Date 11/18/2003
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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