FDA 510(k) Application Details - K013892

Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)

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510(K) Number K013892
Device Name Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant BALLARD MEDICAL PRODUCTS
12050 LONE PEAK PKWY.
DRAPER, UT 84020 US
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Contact SYDNEE F MCMILLAN
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Regulation Number 868.5150

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Classification Product Code BSP
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Date Received 11/23/2001
Decision Date 07/11/2002
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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