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FDA 510(k) Application Details - K072790
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K072790
Device Name
Syringe, Piston
Applicant
CONFLUENT SURGICAL,INC
101A FIRST AVE.
WALTHAM, MA 02451 US
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Contact
VIRGINIA VETTER
Other 510(k) Applications for this Contact
Regulation Number
880.5860
More FDA Info for this Regulation Number
Classification Product Code
FMF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/01/2007
Decision Date
01/11/2008
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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