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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 K972385
Device Name FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED
Applicant
Smiths Industries Medical Systems, Inc.
15 Kit St.
Keene,  NH  03431
Applicant Contact TIMOTHY J TALCOTT
Correspondent
Smiths Industries Medical Systems, Inc.
15 Kit St.
Keene,  NH  03431
Correspondent Contact TIMOTHY J TALCOTT
Regulation Number868.5800
Classification Product Code
JOH  
Date Received06/26/1997
Decision Date 01/20/1998
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
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