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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 K872616
Device Name BELL/MCKAY 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 Number868.5730
Classification Product Code
BTR  
Date Received07/06/1987
Decision Date 08/10/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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