Home / 510(k) Clearances / K980822

510(k) K980822

TITANIUM PEG SYSTEM by Fci Ophthalmics, Inc. — Product Code MQU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1998
Date Received
March 3, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ocular Peg
Device Class
Class II
Regulation Number
886.3320
Review Panel
OP
Submission Type

Other clearances by Fci Ophthalmics, Inc.

  • K061404 — MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE (August 7, 2006)
  • K061398 — SNUG PLUG PUNCTUM PLUG (July 11, 2006)
  • K041869 — SELF RETAINING BICANALICULUS INTUBATION SET (November 18, 2004)
  • K023758 — BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) (September 17, 2003)
  • K023400 — FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT (August 22, 2003)
  • K030054 — DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES (February 26, 2003)
  • 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)
  • K964774 — PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS (December 20, 1996)

Other clearances for product code MQU

  • K000151 — PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE (April 10, 2000)
  • K974203 — PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM (February 4, 1998)
  • K971583 — MEDPOR OCULAR SCREW AND ACCEOSSORIES (June 30, 1997)