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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, electro-acupuncture
510(K) Number K122812
Model WQ-10D1, WQ-6F
Device Name JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS
Applicant
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
room 1706, no.128 songle rd
songjiang area
shanghai, 
Contact doris dong
Classification Product Code
BWK  
Date Received09/13/2012
Decision Date 04/11/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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