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510(k) K151575

Dynarex Eye Cups by Dynarex Corporation — Product Code LXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2015
Date Received
June 11, 2015
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

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Other clearances for product code LXQ

  • K140409 — FLENTS PLASTIC EYE WASH CUP (July 9, 2014)
  • K051414 — EYE CUP, STERILE 1 AND NON STERILE (June 16, 2005)
  • K971134 — VISTA EYESHOWER (November 4, 1997)
  • K881369 — ADVANCE DIAGNOSTICS DISPOSABLE EYECUP (May 13, 1988)