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FDA 510(k) Application Details - K072415
Device Classification Name
More FDA Info for this Device
510(K) Number
K072415
Device Name
STALIF (TM) C
Applicant
SURGICRAFT LTD.
111 HILL ROAD
DOUGLASSVILLE, PA 19518 US
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Contact
DONALD W GUTHNER
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OVE
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Date Received
08/28/2007
Decision Date
01/25/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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