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510(k) K924935

HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT by Polyclinic Medical Center — Product Code KKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1993
Date Received
September 30, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Device Class
Class II
Regulation Number
878.3500
Review Panel
SU
Submission Type

Other clearances by Polyclinic Medical Center

  • K833332 — SCHULTZ ENDHOLD (October 31, 1983)

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