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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Suction, Tracheobronchial
510(k) Number K864468
Device Name TRACHEOBRONCHIAL SUCTION CATHETER
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 Number868.6810
Classification Product Code
BSY  
Date Received11/12/1986
Decision Date 01/06/1987
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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