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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, tracheostomy (w/wo connector)
510(k) Number K860176
Device Name LARYNGECTOMY TUBE, CUFFED
Applicant
SHERIDAN CATHETER CORP.
ROUTE 40
ARGYLE,  NY  12809
Applicant Contact STEEN, PH.D.
Correspondent
SHERIDAN CATHETER CORP.
ROUTE 40
ARGYLE,  NY  12809
Correspondent Contact STEEN, PH.D.
Regulation Number868.5800
Classification Product Code
BTO  
Date Received01/17/1986
Decision Date 01/27/1986
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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