FDA 510(k) Application Details - K983754

Device Classification Name Prosthesis, Chin, Internal

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510(K) Number K983754
Device Name Prosthesis, Chin, Internal
Applicant SURGICAL TECHNOLOGY LABORATORIES, INC.
1588 EAST 40TH ST.
CLEVELAND, OH 44103 US
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Contact RICHARD T NOCK
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Regulation Number 878.3550

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Classification Product Code FWP
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Date Received 10/22/1998
Decision Date 11/20/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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