FDA 510(k) Application Details - K091011

Device Classification Name Prosthesis, Chin, Internal

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510(K) Number K091011
Device Name Prosthesis, Chin, Internal
Applicant SURGICAL TECHNOLOGY LABORATORIES, INC ("STL")
610 CLEMSON ROAD
COLUMBIA, SC 29229 US
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Contact MATHEW FAIRFAX
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Regulation Number 878.3550

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Classification Product Code FWP
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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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