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FDA 510(k) Application Details - K002127
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K002127
Device Name
Syringe, Piston
Applicant
STERLING MEDIVATIONS, INC.
180 FERNDALE RD. SOUTH
WAYZATA, MN 55391 US
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Contact
JOEL DOUGLAS
Other 510(k) Applications for this Contact
Regulation Number
880.5860
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Classification Product Code
FMF
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More FDA Info for this Product Code
Date Received
07/14/2000
Decision Date
12/29/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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