FDA 510(k) Application Details - K981850

Device Classification Name Prosthesis, Chin, Internal

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510(K) Number K981850
Device Name Prosthesis, Chin, Internal
Applicant SILIMED, LLC.
P.O BOX 4341
CROFTON, MD 21114 US
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Contact E.J. Smith
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Regulation Number 878.3550

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Classification Product Code FWP
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Date Received 05/26/1998
Decision Date 07/09/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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