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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 K980466
Device Name PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
Applicant
Sims Portex, Inc.
10 Bowman Dr.
Keene,  NH  03431
Applicant Contact TIMOTHY J TALCOTT
Correspondent
Sims Portex, Inc.
10 Bowman Dr.
Keene,  NH  03431
Correspondent Contact TIMOTHY J TALCOTT
Regulation Number868.5800
Classification Product Code
JOH  
Date Received02/06/1998
Decision Date 02/24/1998
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
Recalls CDRH Recalls
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