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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/Bronchial, Differential Ventilation (W/Wo Connector)
510(k) Number K897046
Device Name LASER RESISTANT TRACHEAL TUBE
Applicant
SHERIDAN CATHETER CORP.
ROUTE 40
ARGYLE,  NY  12809
Applicant Contact STEEN, PHD
Correspondent
SHERIDAN CATHETER CORP.
ROUTE 40
ARGYLE,  NY  12809
Correspondent Contact STEEN, PHD
Regulation Number868.5740
Classification Product Code
CBI  
Date Received12/18/1989
Decision Date 03/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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