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FDA 510(k) Application Details - K172483
Device Classification Name
Needle, Hypodermic, Single Lumen
More FDA Info for this Device
510(K) Number
K172483
Device Name
Needle, Hypodermic, Single Lumen
Applicant
Poonglim Pharmatech Inc.
21, Jayumuyeok 1-gil
Gunsan-si 54001 KR
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Contact
Cho Hee Min
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
08/16/2017
Decision Date
06/21/2018
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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