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510(k) K073293

DURETTE IMPLANT by Oculo Plastik, Inc. — Product Code HPZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2008
Date Received
November 23, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Eye Sphere
Device Class
Class II
Regulation Number
886.3320
Review Panel
OP
Submission Type

Other clearances by Oculo Plastik, Inc.

  • K112176 — SILICONE SPHERES (September 15, 2011)
  • K040689 — EYE SPHERE IMPLANTS (June 10, 2004)
  • K934834 — EPTFE SHEET COVERING FOR OCULAR IMPLANT (May 5, 1994)
  • K915630 — OPHTIMPLANT (March 2, 1992)
  • K901002 — O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES (May 22, 1990)
  • K900929 — PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL (May 18, 1990)
  • K900927 — CODERE-DURETTE ORBITAL FLOOR IMPLANT (May 15, 1990)
  • K900930 — SPIVEY-ALLEN ORBITAL FLOOR IMPLANT (May 15, 1990)
  • K900928 — COX MALAR EMINENCE IMPLANTS (May 15, 1990)
  • K900081 — NEW ALLEN IMPLANT (March 23, 1990)

Other clearances for product code HPZ

  • K212741 — EZYPOR (June 24, 2022)
  • K123764 — DURETTE OCULAR IMPLANT (January 31, 2013)
  • K110554 — BIOCERAMIC ORBITAL IMPLANT, ORBTEX (November 2, 2011)
  • K112176 — SILICONE SPHERES (September 15, 2011)
  • K083342 — ORBITAL RECONSTRUCTIVE IMPLANT II (March 12, 2009)
  • K082850 — EYE SPHERES (February 27, 2009)
  • K071335 — MEDPOR ATTRACTOR IMPLANT (August 8, 2007)
  • K070130 — ORBITAL RECONSTRUCTIVE IMPLANT (April 19, 2007)
  • K053298 — ALPHASPHERE ORBITAL IMPLANT (May 9, 2006)
  • K040851 — MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM (July 16, 2004)