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FDA 510(k) Application Details - K171982
Device Classification Name
Needle, Hypodermic, Single Lumen
More FDA Info for this Device
510(K) Number
K171982
Device Name
Needle, Hypodermic, Single Lumen
Applicant
HTL-STREFA S.A.
Adamowek 7
Ozorkow 95-035 PL
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Contact
Aleksandra Prazmowska-Wilanowska
Other 510(k) Applications for this Contact
Regulation Number
880.5570
More FDA Info for this Regulation Number
Classification Product Code
FMI
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More FDA Info for this Product Code
Date Received
06/30/2017
Decision Date
03/21/2018
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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