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510(k) K112176

SILICONE SPHERES by Oculo Plastik, Inc. — Product Code HPZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2011
Date Received
July 28, 2011
Clearance Type
Special
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.

  • K073293 — DURETTE IMPLANT (March 19, 2008)
  • 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)
  • K900928 — COX MALAR EMINENCE IMPLANTS (May 15, 1990)
  • K900930 — SPIVEY-ALLEN ORBITAL FLOOR IMPLANT (May 15, 1990)
  • K900080 — NEW IOWA MOTILITY 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)
  • K083342 — ORBITAL RECONSTRUCTIVE IMPLANT II (March 12, 2009)
  • K082850 — EYE SPHERES (February 27, 2009)
  • K073293 — DURETTE IMPLANT (March 19, 2008)
  • 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)