FDA 510(k) Application Details - K960349

Device Classification Name Prosthesis, Chin, Internal

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510(K) Number K960349
Device Name Prosthesis, Chin, Internal
Applicant CERAMED CORP.
12860 WEST CEDAR DR., STE. 110
LAKEWOOD, CO 80228 US
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Contact BARBARA A WATSON
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Regulation Number 878.3550

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Classification Product Code FWP
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Date Received 01/25/1996
Decision Date 03/13/1996
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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