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FDA 510(k) Application Details - K150903
Device Classification Name
Needle, Acupuncture, Single Use
More FDA Info for this Device
510(K) Number
K150903
Device Name
Needle, Acupuncture, Single Use
Applicant
MAANSHAN BOND MEDICAL INSTRUMENTS CO., LTD.
1358 Meishan Road, Economic & Technology Development Zone
Maanshan 243041 CN
Other 510(k) Applications for this Company
Contact
Viva Gu
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
04/03/2015
Decision Date
07/15/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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