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FDA 510(k) Application Details - K140710
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K140710
Device Name
Syringe, Piston
Applicant
BIOMET SPINE (AKA EBI, LLC)
399 JEFFERSON ROAD
PARSIPPANY, NJ 07054 US
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Contact
DEBRA L BING
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
03/21/2014
Decision Date
09/04/2014
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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