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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 K060094
Device Name ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES
Applicant
ARCADIA MEDICAL CORPORATION
1450 EAST AMERICAN LANE
SUITE 1400
SCHAUMBURG,  IL  60173
Applicant Contact MARK FOOTE
Correspondent
ARCADIA MEDICAL CORPORATION
1450 EAST AMERICAN LANE
SUITE 1400
SCHAUMBURG,  IL  60173
Correspondent Contact MARK FOOTE
Regulation Number868.5730
Classification Product Code
BTR  
Date Received01/12/2006
Decision Date 05/08/2006
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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