Home / 510(k) Clearances / K843195

510(k) K843195

VISITEC FLIERINGA-LEGRAND FIXATION RING by Visitec Co. — Product Code HMH

K843195 is an FDA 510(k) premarket notification submitted by Visitec Co. for the device "VISITEC FLIERINGA-LEGRAND FIXATION RING". The FDA issued a decision of Substantially Equivalent on October 5, 1984. The device falls under product code HMH (Rack, Skiascopic), a Class I device regulated under 21 CFR 886.1750. Visitec Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1984
Date Received
August 14, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rack, Skiascopic
Device Class
Class I
Regulation Number
886.1750
Review Panel
OP
Submission Type

Other clearances by Visitec Co.

  • K953394 — VISITEC COLLAR BUTTON CATHETER {GRIFFITHS} (October 12, 1995)
  • K945114 — VISITEC SCLERAL PLUG (February 23, 1995)
  • K945738 — VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE (February 14, 1995)
  • K945172 — VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS (January 17, 1995)
  • K942234 — VISITEC PRECISE-POINT (July 12, 1994)
  • K934269 — FIBEROPTIC ILLUMINATED INSTRUMENTS (May 17, 1994)
  • K940210 — VISITEC EYE PAD (March 7, 1994)
  • K933872 — VISI-SPEAR EYE SPONGE (December 27, 1993)
  • K923972 — OPHTHALMIC FLUID DISTRIBUTION SETS (November 4, 1992)
  • K922530 — VISITEC MICROSURGICAL SUTURE (October 20, 1992)

Other clearances for product code HMH

  • K844364 — SKIASCOPIC RACKS (January 2, 1985)

FDA data resources