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FDA 510(k) Application Details - K102641
Device Classification Name
Plate, Bone
More FDA Info for this Device
510(K) Number
K102641
Device Name
Plate, Bone
Applicant
NEOORTHO PRODUTOS ORTOPEDICOS S/A
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO, CA 92130 US
Other 510(k) Applications for this Company
Contact
LINDA K SCHULZ
Other 510(k) Applications for this Contact
Regulation Number
872.4760
More FDA Info for this Regulation Number
Classification Product Code
JEY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/13/2010
Decision Date
12/20/2010
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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