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FDA 510(k) Application Details - K984230
Device Classification Name
Plate, Bone
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510(K) Number
K984230
Device Name
Plate, Bone
Applicant
OSTEOGENICS BIOMEDICAL, INC.
6401 MEADOWS WEST DR.
FORT WORTH, TX 76132 US
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Contact
RICHARD A HAMER
Other 510(k) Applications for this Contact
Regulation Number
872.4760
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Classification Product Code
JEY
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More FDA Info for this Product Code
Date Received
11/25/1998
Decision Date
02/04/1999
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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