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FDA 510(k) Application Details - K120191
Device Classification Name
Needle, Hypodermic, Single Lumen
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510(K) Number
K120191
Device Name
Needle, Hypodermic, Single Lumen
Applicant
SCANDINAVIAN HEALTH LIMITED
NO. 136, KUO SHENG
2ND STREET
TAOYUAN CITY 33060 TW
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Contact
SHARLIN YEH
Other 510(k) Applications for this Contact
Regulation Number
880.5570
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Classification Product Code
FMI
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More FDA Info for this Product Code
Date Received
01/23/2012
Decision Date
05/23/2012
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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