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FDA 510(k) Application Details - K170435
Device Classification Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
More FDA Info for this Device
510(K) Number
K170435
Device Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant
PAJUNK GmbH Medizintechnologie
Karl-Hall-Str. 1
Geisingen 78187 DE
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Contact
Christian G.H. Quass
Other 510(k) Applications for this Contact
Regulation Number
868.5150
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Classification Product Code
BSP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/13/2017
Decision Date
07/12/2017
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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