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510(k) K900928

COX MALAR EMINENCE IMPLANTS by Oculo Plastik, Inc. — Product Code HQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1990
Date Received
February 27, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Orbital, Extra-Ocular
Device Class
Class II
Regulation Number
886.3340
Review Panel
OP
Submission Type

Other clearances by Oculo Plastik, Inc.

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  • 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)
  • K900930 — SPIVEY-ALLEN ORBITAL FLOOR IMPLANT (May 15, 1990)
  • K900927 — CODERE-DURETTE ORBITAL FLOOR IMPLANT (May 15, 1990)
  • K900080 — NEW IOWA MOTILITY IMPLANT (March 23, 1990)

Other clearances for product code HQX

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  • K983581 — OCU-GUARD AND OCU-GUARD SUPPLE (November 6, 1998)
  • K980816 — RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES (September 18, 1998)
  • K963219 — RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND S (October 28, 1996)
  • K950806 — SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS (June 5, 1996)
  • K950599 — STORS SCLERAL SPONGE II (LINCOFF DESIGN) (March 2, 1995)
  • K945172 — VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS (January 17, 1995)
  • K902308 — TAMCENAN OCULAR EXPLANTS AND BANDS (June 19, 1990)
  • K901002 — O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES (May 22, 1990)
  • K900929 — PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL (May 18, 1990)