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FDA 510(k) Application Details - K102845
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K102845
Device Name
Plate, Fixation, Bone
Applicant
MAHE MEDICAL GMBH
SCHWARZWALDSTRASSE 5
TUTTLINGEN, BW 78532 GR
Other 510(k) Applications for this Company
Contact
ANDREA PECSI
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/29/2010
Decision Date
05/13/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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