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510(k) K070628

OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS. by Contamac, Ltd. — Product Code HQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2007
Date Received
March 7, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact (Other Material) - Daily
Device Class
Class II
Regulation Number
886.5916
Review Panel
OP
Submission Type

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  • K161100 — Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses (August 10, 2016)
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  • K150590 — CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFL (July 10, 2015)
  • K081178 — OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LEN (October 9, 2008)

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