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510(k) K934861

HARD TISSUE REPLACEMENT (HTR) GRANULAR by Poly-Medics,Inc. — Product Code KKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1994
Date Received
October 12, 1993
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 Poly-Medics,Inc.

  • K960988 — LACTOSORB TRAUMA PLATING SYSTEM (April 10, 1996)
  • K955729 — LACTOSORB TRAUMA PLATING SYSTEM (February 14, 1996)
  • K954443 — LACTOSORB SUTURE ANCHOR (January 31, 1996)
  • K951658 — LACTOSORB POP RIVET (July 25, 1995)

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  • K103010 — STRYKER PATIENT SPECIFIC POLYMER IMPLANT (October 26, 2010)