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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 K960429
Device Name PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA
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 Received01/31/1996
Decision Date 05/02/1996
Decision Substantially Equivalent - Kit (SESK)
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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