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FDA 510(k) Application Details - K160575
Device Classification Name
Needle, Hypodermic, Single Lumen
More FDA Info for this Device
510(K) Number
K160575
Device Name
Needle, Hypodermic, Single Lumen
Applicant
YIDOBIO INC.
#3-1, 59-12, DONG4-GIL, HYANGNAM-EUP
HWASEONG-SI 18624 KR
Other 510(k) Applications for this Company
Contact
KYUNG HEE YOON
Other 510(k) Applications for this Contact
Regulation Number
880.5570
More FDA Info for this Regulation Number
Classification Product Code
FMI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/01/2016
Decision Date
09/07/2016
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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