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510(k) K140409

FLENTS PLASTIC EYE WASH CUP by Apothecary Products, Inc. — Product Code LXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2014
Date Received
February 18, 2014
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 by Apothecary Products, Inc.

  • K111856 — SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS C (July 14, 2011)
  • K041766 — EZY-TRAVEL WRISTBAND (November 26, 2004)
  • K020296 — ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057 (June 25, 2002)
  • K892242 — PATIENT EXAMINATION GLOVES (LATEX) (May 12, 1989)
  • K833311 — NITROGLYCERINE CONTAINER (February 4, 1984)

Other clearances for product code LXQ

  • K151575 — Dynarex Eye Cups (September 1, 2015)
  • 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)