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FDA 510(k) Application Details - K120475
Device Classification Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
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510(K) Number
K120475
Device Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant
SHANGHAI SA MEDICAL & PLASTIC INSTRUMENTS CO., LTD
7TH FL, JINGUI BUSINESS BLDG.
NO. 982 CONGYUM RD
BAIYUM DISTRICT, GUANGZHOU 510420 CN
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Contact
MIKE GU
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
02/16/2012
Decision Date
12/21/2012
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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