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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 K131006
Device Name ANESTHESIA CONDUCTION NEEDLES
Applicant
LCCS PRODUCTS LIMITED
7TH FLOOR, JINGGUI BUSINESS BUILDING, NO. 982 CONGYUN RD.,
BAIYUN DISTRICT
GUANGZHOU, GUANGDONG,  CN 510420
Applicant Contact MIKE GU
Correspondent
LCCS PRODUCTS LIMITED
7TH FLOOR, JINGGUI BUSINESS BUILDING, NO. 982 CONGYUN RD.,
BAIYUN DISTRICT
GUANGZHOU, GUANGDONG,  CN 510420
Correspondent Contact MIKE GU
Regulation Number868.5150
Classification Product Code
BSP  
Date Received04/11/2013
Decision Date 12/06/2013
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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