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FDA 510(k) Application Details - K072005
Device Classification Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
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510(K) Number
K072005
Device Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant
EPIMED INTERNATIONAL
141 SAL LANDRIO DR.
JOHNSTOWN, NY 12095 US
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Contact
KATIE ALEXANDER
Other 510(k) Applications for this Contact
Regulation Number
868.5150
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Classification Product Code
BSP
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More FDA Info for this Product Code
Date Received
07/23/2007
Decision Date
02/07/2008
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
Y
Expedited Review
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