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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Flexlens Multifocal; Westcon Horizon Bi-Con; Westcon Horizon Bi-Con Toric; Westcon Horizon Large Diameter; Westcon Horizon Prism Sphere; Westcon Horizon Progressive; Westcon Horizon Progressive Toric; Westcon Horizon Sphere; Westcon Horizon Toric; Westcon Westhin Toric
Classification Name: LENSES, SOFT CONTACT, DAILY WEAR
Product Code: LPL
Device Class: 2
Regulation Number: 886.5925
Medical Specialty: Ophthalmic
Registered Establishment Name: X-CEL SPECIALTY CONTACTS
Registered Establishment Number: 1065845
Premarket Submission Number: K031774
Owner/Operator: Walman Optical
Owner/Operator Number: 2125182
Establishment Operations: Manufacturer
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