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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Airway, Esophageal (Obturator)
510(k) Number K875226
Device Name ESOPHAGEAL OBTURATOR/TRACHEAL TUBE
Applicant
SHERIDAN CATHETER CORP.
ROUTE 40
ARGYLE,  NY  12809
Applicant Contact JOHN STEEN
Correspondent
SHERIDAN CATHETER CORP.
ROUTE 40
ARGYLE,  NY  12809
Correspondent Contact JOHN STEEN
Regulation Number868.5650
Classification Product Code
CAO  
Date Received12/22/1987
Decision Date 01/19/1988
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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