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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 K910908
Device Name MUCAID WITH SUCTION CATHETER AND EXTENSION TUBING
Applicant
Vygon Corp.
227 Broadway
Suite 100
New York,  NY  10007
Applicant Contact HARRY A SCHLAKMAN
Correspondent
Vygon Corp.
227 Broadway
Suite 100
New York,  NY  10007
Correspondent Contact HARRY A SCHLAKMAN
Regulation Number868.6810
Classification Product Code
BSY  
Date Received03/05/1991
Decision Date 05/20/1991
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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