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FDA 510(k) Application Details - K993972
Device Classification Name
Pump, Infusion, Elastomeric
More FDA Info for this Device
510(K) Number
K993972
Device Name
Pump, Infusion, Elastomeric
Applicant
BIOMET, INC.
AIRPORT INDUSTRIAL PARK,
P.O.BOX 587
WARSAW, IN 46581-0587 US
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Contact
PATRICIA SANDBORN BERES
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Regulation Number
880.5725
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Classification Product Code
MEB
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More FDA Info for this Product Code
Date Received
11/23/1999
Decision Date
02/07/2000
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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