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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
Recalls CDRH Recalls
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