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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Alden HP54 Sphere Soft Contact Lens (catalog# AOHPS54); Alden HP54 Toric Soft Contact Lens (catalog# AOHPT54); ASTERA Multifocal Soft Contact Lens (catalog# AOAMS54); ASTERA Multifocal Toric Soft Contact Lens (catalog# AOAMT54)
Classification Name: LENSES, SOFT CONTACT, DAILY WEAR
Product Code: LPL
Device Class: 2
Regulation Number: 886.5925
Medical Specialty: Ophthalmic
Registered Establishment Name: ALDEN OPTICAL LABS., INC.
Registered Establishment Number: 1315522
Owner/Operator: ALDEN OPTICAL LABS., INC.
Owner/Operator Number: 1315522
Establishment Operations: Manufacturer
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