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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, conduction, anesthetic (w/wo introducer)
510(k) Number K120475
Device Name ANESTHESIA CONDUCTION NEEDLES
Applicant
SHANGHAI SA MEDICAL & PLASTIC INSTRUMENTS CO., LTD
7TH FL, JINGUI BUSINESS BLDG.
NO. 982 CONGYUM RD
BAIYUM DISTRICT, GUANGZHOU,  CN 510420
Applicant Contact MIKE GU
Correspondent
SHANGHAI SA MEDICAL & PLASTIC INSTRUMENTS CO., LTD
7TH FL, JINGUI BUSINESS BLDG.
NO. 982 CONGYUM RD
BAIYUM DISTRICT, GUANGZHOU,  CN 510420
Correspondent Contact MIKE GU
Regulation Number868.5150
Classification Product Code
BSP  
Date Received02/16/2012
Decision Date 12/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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