FDA 510(k) Application Details - K000045

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

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510(K) Number K000045
Device Name Tube, Tracheal (W/Wo Connector)
Applicant PARAPRODUCTS, INC.
1431 INDUSTRIAL DR.
ITASCA, IL 60143 US
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Contact JAMES FLORY
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Regulation Number 868.5730

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Classification Product Code BTR
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Date Received 01/07/2000
Decision Date 03/15/2000
Decision SESE - SUBST EQUIV
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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