FDA 510(k) Application Details - K050166

Device Classification Name Needle, Emergency Airway

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510(K) Number K050166
Device Name Needle, Emergency Airway
Applicant SMITHS MEDICAL
MILITARY ROAD
HYTHE, KENT CT 21 5BN GB
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Contact CHRISTOPHER TURNBULL
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Regulation Number 868.5090

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Classification Product Code BWC
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Date Received 01/26/2005
Decision Date 05/26/2005
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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