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510(k) K963219

RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES by Fci Ophthalmics, Inc. — Product Code HQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1996
Date Received
August 16, 1996
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

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  • K992294 — BIOCERAMIC ORBITAL IMPLANT (April 19, 2000)
  • K991238 — FCI CRAWFORD PROBE INTUBATION SETS (July 8, 1999)
  • K980816 — RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES (September 18, 1998)
  • K980822 — TITANIUM PEG SYSTEM (July 9, 1998)

Other clearances for product code HQX

  • K023481 — MICROVISION SCLERAL BUCKLING COMPONENTS (January 8, 2003)
  • K983581 — OCU-GUARD AND OCU-GUARD SUPPLE (November 6, 1998)
  • K980816 — RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES (September 18, 1998)
  • 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)
  • K900927 — CODERE-DURETTE ORBITAL FLOOR IMPLANT (May 15, 1990)