FDA 510(k) Application Details - K041311

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

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510(K) Number K041311
Device Name Tube, Tracheal (W/Wo Connector)
Applicant TIGER MEDICAL PRODUCTS LTD
1308 MORNINGSIDE PARK DRIVE
ALPHARETTA, GA 30022 US
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Contact JAY MANSOUR
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Regulation Number 868.5730

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Classification Product Code BTR
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Date Received 05/17/2004
Decision Date 03/18/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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