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FDA 510(k) Application Details - K111538
Device Classification Name
Wax,Bone
More FDA Info for this Device
510(K) Number
K111538
Device Name
Wax,Bone
Applicant
SKELETAL KINETICS, LLC
10201 BUBB RD.
CUPERTINO, CA 95014-4167 US
Other 510(k) Applications for this Company
Contact
CHRISTINE KUO
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MTJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/02/2011
Decision Date
10/25/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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