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FDA 510(k) Application Details - K012908
Device Classification Name
Screw, Fixation, Intraosseous
More FDA Info for this Device
510(K) Number
K012908
Device Name
Screw, Fixation, Intraosseous
Applicant
BIOPLATE, INC.
6911 MELROSE AVE.
LOS ANGELES, CA 90038 US
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Contact
ERIC V HOHENSTEIN
Other 510(k) Applications for this Contact
Regulation Number
872.4880
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Classification Product Code
DZL
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More FDA Info for this Product Code
Date Received
08/30/2001
Decision Date
11/28/2001
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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