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FDA 510(k) Application Details - K990944
Device Classification Name
External Mandibular Fixator And/Or Distractor
More FDA Info for this Device
510(K) Number
K990944
Device Name
External Mandibular Fixator And/Or Distractor
Applicant
OSTEOMED CORP.
3750 REALTY RD.
ADDISON, TX 75001-4311 US
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Contact
RICK A BUSS
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
03/22/1999
Decision Date
06/16/1999
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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