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FDA 510(k) Application Details - K955640
Device Classification Name
External Mandibular Fixator And/Or Distractor
More FDA Info for this Device
510(K) Number
K955640
Device Name
External Mandibular Fixator And/Or Distractor
Applicant
BIOMET, INC.
AIRPORT INDUSTRIAL PARK,
P.O.BOX 587
WARSAW, IN 46581-0587 US
Other 510(k) Applications for this Company
Contact
MARY VERSTYNEN
Other 510(k) Applications for this Contact
Regulation Number
872.4760
More FDA Info for this Regulation Number
Classification Product Code
MQN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/12/1995
Decision Date
02/14/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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