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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 K896321
Device Name NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH.
Applicant
Superior Healthcare Group, Inc.
Cumberland Industrial Park
Cumberland,  RI  02864
Applicant Contact PAUL BERNARD
Correspondent
Superior Healthcare Group, Inc.
Cumberland Industrial Park
Cumberland,  RI  02864
Correspondent Contact PAUL BERNARD
Regulation Number868.6810
Classification Product Code
BSY  
Date Received11/01/1989
Decision Date 11/13/1989
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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