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FDA 510(k) Application Details - K091722
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K091722
Device Name
Syringe, Piston
Applicant
BIOMET, INC.
56 EAST BELL DR.
BOX 587
WARSAW, IN 46581-0587 US
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Contact
ELIZABETH WRAY
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
06/11/2009
Decision Date
03/12/2010
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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