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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
Device Name JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS
Applicant
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
ROOM 1706, NO.128 SONGLE RD
SONGJIANG AREA
SHANGHAI,  CN 201600
Applicant Contact DORIS DONG
Correspondent
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
ROOM 1706, NO.128 SONGLE RD
SONGJIANG AREA
SHANGHAI,  CN 201600
Correspondent Contact DORIS DONG
Classification Product Code
BWK  
Date Received09/13/2012
Decision Date 04/11/2013
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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