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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 Samedical & Plastic Instruments Co., Ltd.
7th Floor, Jingui Business Bldg.
# 982 Congyum Rd.
Baiyum District, Guangzhou,  CN 510420
Applicant Contact MIKE GU
Correspondent
Shanghai Samedical & Plastic Instruments Co., Ltd.
7th Floor, Jingui Business Bldg.
# 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
Predetermined Change
Control Plan Authorized		 No
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