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510(k) K180819

One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens by Menicon Co, Ltd. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2018
Date Received
March 29, 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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  • 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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