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510(k) K161100

Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses by Contamac, Ltd. — Product Code HQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2016
Date Received
April 19, 2016
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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  • K081178 — OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LEN (October 9, 2008)
  • K070628 — OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS. (May 1, 2007)

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