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FDA 510(k) Application Details - K073307
Device Classification Name
Plate, Bone
More FDA Info for this Device
510(K) Number
K073307
Device Name
Plate, Bone
Applicant
BIO-TECHNOLOGY USA, INC.
1705 S. CAPITOL OF TEXAS HWY.
AUSTIN, TX 78746 US
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Contact
IAN GORDON
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
11/23/2007
Decision Date
10/29/2008
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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