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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 K851856
Device Name TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE
Applicant
SHERIDAN CATHETER CORP.
ROUTE 40
ARGYLE,  NY  12809
Applicant Contact JOHN S STEEN
Correspondent
SHERIDAN CATHETER CORP.
ROUTE 40
ARGYLE,  NY  12809
Correspondent Contact JOHN S STEEN
Regulation Number868.5740
Classification Product Code
CBI  
Date Received04/26/1985
Decision Date 05/23/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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