FDA 510(k) Application Details - K962098

Device Classification Name Tube, Tracheal (W/Wo Connector)

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510(K) Number K962098
Device Name Tube, Tracheal (W/Wo Connector)
Applicant KIRK SPECIALTY SYSTEMS
1625 CRESCENT CIR., STE. 225
CARROLLTON, TX 75006 US
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Contact DALE B ICKLEY
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Regulation Number 868.5730

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Classification Product Code BTR
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Date Received 05/29/1996
Decision Date 10/08/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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