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FDA 510(k) Application Details - K052667
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K052667
Device Name
Syringe, Piston
Applicant
ARTSANA S.P.A.
22411 60TH STREET
BRISTOL, WI 53104 US
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Contact
LARA N SIMMONS
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
09/27/2005
Decision Date
11/25/2005
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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