SHENLING ACUPUNCTURE NEEDLES

Needle, Acupuncture, Single Use

SHENLING MEDICAL DEVICE CO., LTD

The following data is part of a premarket notification filed by Shenling Medical Device Co., Ltd with the FDA for Shenling Acupuncture Needles.

Pre-market Notification Details

Device IDK002411
510k NumberK002411
Device Name:SHENLING ACUPUNCTURE NEEDLES
ClassificationNeedle, Acupuncture, Single Use
Applicant SHENLING MEDICAL DEVICE CO., LTD 1800 CENTURY PARK EAST SUITE 600 Los Angeles,  CA  90067 -1509
ContactGeorge Su
CorrespondentGeorge Su
SHENLING MEDICAL DEVICE CO., LTD 1800 CENTURY PARK EAST SUITE 600 Los Angeles,  CA  90067 -1509
Product CodeMQX  
CFR Regulation Number880.5580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-08-07
Decision Date2000-12-12

NIH GUDID Devices

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