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FDA 510(k) Application Details - K050924
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K050924
Device Name
Screw, Fixation, Bone
Applicant
MERETE MEDICAL GMBH
269 WEST SEVENTY-FIRST STREET
NEW YORK, NY 10023 US
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Contact
JENIK RADON
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/13/2005
Decision Date
05/27/2005
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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