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FDA 510(k) Applications Submitted by Rob Mcgregor
FDA 510(k) Number
Submission Date
Device Name
Applicant
K180616
03/08/2018
OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens
Contamac Ltd.
K150590
03/09/2015
CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,
CONTAMAC LTD
K160859
03/29/2016
OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)
CONTAMAC LTD.
K171077
04/11/2017
HEXA100 (hexafocon A) Daily Wear Contact Lenses
CONTAMAC Ltd.
K161100
04/19/2016
Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses
CONTAMAC LTD.
K171575
05/30/2017
ENFLU 18 (enflufocon A) Daily Wear Contact Lens
CONTAMAC Ltd.
K181566
06/14/2018
Nutrifill
Contamac Ltd.
K212631
08/19/2021
Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses
Contamac Ltd.
K182304
08/24/2018
Hyper GP (tisilfocon A) Daily Wear Contact Lens
CONTAMAC LTD.
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