Home / 510(k) Clearances / K051414

510(k) K051414

EYE CUP, STERILE 1 AND NON STERILE by Tollot Pty.Ltd.(Aaxis Pacific) — Product Code LXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2005
Date Received
May 31, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cup, Eye
Device Class
Class U
Regulation Number
Review Panel
OP
Submission Type

Other clearances for product code LXQ

  • K151575 — Dynarex Eye Cups (September 1, 2015)
  • K140409 — FLENTS PLASTIC EYE WASH CUP (July 9, 2014)
  • K971134 — VISTA EYESHOWER (November 4, 1997)
  • K881369 — ADVANCE DIAGNOSTICS DISPOSABLE EYECUP (May 13, 1988)