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510(k) K023349

CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) by Contamac, Ltd. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 2002
Date Received
October 7, 2002
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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  • K081178 — OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LEN (October 9, 2008)

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