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FDA 510(k) Application Details - K091011
Device Classification Name
Prosthesis, Chin, Internal
More FDA Info for this Device
510(K) Number
K091011
Device Name
Prosthesis, Chin, Internal
Applicant
SURGICAL TECHNOLOGY LABORATORIES, INC ("STL")
610 CLEMSON ROAD
COLUMBIA, SC 29229 US
Other 510(k) Applications for this Company
Contact
MATHEW FAIRFAX
Other 510(k) Applications for this Contact
Regulation Number
878.3550
More FDA Info for this Regulation Number
Classification Product Code
FWP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/09/2009
Decision Date
04/22/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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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