FDA 510(k) Application Details - K935199

Device Classification Name Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

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510(K) Number K935199
Device Name Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Applicant ASSOCIATED HOSPITAL SERVICES, INC.
7639 TOWNSEND PLACE
NEW ORLEANS, LA US
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Contact LOU SCHULTZ
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Regulation Number 878.3500

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Classification Product Code KKY
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Date Received 10/27/1993
Decision Date 09/30/1994
Decision SE - Substantially Equivalent
Classification Advisory Committee HO - General Hospital
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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