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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 And Tube Cuff
510(k) Number K963732
Device Name PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA
Applicant
Mallinckrodt Medical
675 Mcdonnell Blvd. P.O. Box
5840
St Louis,  MO  63134
Applicant Contact MICHAEL B SCHOECK
Correspondent
Mallinckrodt Medical
675 Mcdonnell Blvd. P.O. Box
5840
St Louis,  MO  63134
Correspondent Contact MICHAEL B SCHOECK
Regulation Number868.5800
Classification Product Code
JOH  
Date Received09/17/1996
Decision Date 06/26/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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