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FDA 510(k) Application Details - K002207
Device Classification Name
Plate, Bone
More FDA Info for this Device
510(K) Number
K002207
Device Name
Plate, Bone
Applicant
MACROPORE BIOSURGERY, INC.
6740 TOP GUN ST.
SAN DIEGO, CA 92121 US
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Contact
KENNETH K KLEINHENZ
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
07/21/2000
Decision Date
07/11/2001
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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