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510(k) K980466

PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA by Sims Portex, Inc. — Product Code JOH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1998
Date Received
February 6, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube Tracheostomy And Tube Cuff
Device Class
Class II
Regulation Number
868.5800
Review Panel
AN
Submission Type

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  • K994275 — SIMS PORTEX ANESTHESIA CATHETER (February 22, 2000)

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