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
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Regulation Number 868.5150

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Classification Product Code BSP
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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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