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FDA 510(k) Application Details - K002180
Device Classification Name
Needle, Hypodermic, Single Lumen
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510(K) Number
K002180
Device Name
Needle, Hypodermic, Single Lumen
Applicant
STERLING MEDIVATIONS, INC.
180 FERNDALE RD. SOUTH
WAYZATA, MN 55391 US
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Contact
JOEL DOUGLAS
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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
07/19/2000
Decision Date
10/13/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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