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510(k) K180004

Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens by Menicon Co, Ltd. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2018
Date Received
January 2, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lenses, Soft Contact, Daily Wear
Device Class
Class II
Regulation Number
886.5925
Review Panel
OP
Submission Type

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  • K102895 — ONE DAY FLAT PACK (April 28, 2011)
  • K103561 — MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS (February 3, 2011)
  • K082855 — MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES (March 9, 2010)

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