FDA 510(k) Application Details - K960429

Device Classification Name Tube Tracheostomy And Tube Cuff

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510(K) Number K960429
Device Name Tube Tracheostomy And Tube Cuff
Applicant SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
15 KIT ST.
KEENE, NH 03431 US
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Contact TIMOTHY J TALCOTT
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Regulation Number 868.5800

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Classification Product Code JOH
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Date Received 01/31/1996
Decision Date 05/02/1996
Decision SESK - SUBST EQUIV - KIT
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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