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FDA 510(k) Application Details - K142920
Device Classification Name
Needle, Acupuncture, Single Use
More FDA Info for this Device
510(K) Number
K142920
Device Name
Needle, Acupuncture, Single Use
Applicant
K.M.S. INC.
F2, 81-1 HAENFJEONG-RI, GWANGDEOK-MYEON, DONGNAM-GU
CHEONAN-SI 330922 KR
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Contact
CHUL HUI KIM
Other 510(k) Applications for this Contact
Regulation Number
880.5580
More FDA Info for this Regulation Number
Classification Product Code
MQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/08/2014
Decision Date
06/10/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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