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FDA 510(k) Application Details - K013892
Device Classification Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
More FDA Info for this Device
510(K) Number
K013892
Device Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant
BALLARD MEDICAL PRODUCTS
12050 LONE PEAK PKWY.
DRAPER, UT 84020 US
Other 510(k) Applications for this Company
Contact
SYDNEE F MCMILLAN
Other 510(k) Applications for this Contact
Regulation Number
868.5150
More FDA Info for this Regulation Number
Classification Product Code
BSP
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More FDA Info for this Product Code
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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