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FDA 510(k) Application Details - K152256
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K152256
Device Name
Plate, Fixation, Bone
Applicant
NORMED MEDIZIN-TECHNIK GMBH
ULRICHSTRASSE 7
TUTTLINGEN D-78532 DE
Other 510(k) Applications for this Company
Contact
ARNE BRIEST
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
08/10/2015
Decision Date
11/05/2015
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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