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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: AAB00, Sensar One Piece Intraocular Lens; AR40e, AMO Sensar Intraocular Lens; ZCB00, TECNIS 1-piece Intraocular Lens; ZCT150, ZCT225, ZCT300, ZCT400, TECNIS Toric 1-Piece Intraocular Lens; ZMB00, Tecnis Multi focal 1-Piece Intraocular Lens
Classification Name: INTRAOCULAR LENS
Product Code: HQL
Device Class: 3
Regulation Number: 886.3600
Medical Specialty: Ophthalmic
Registered Establishment Name: ABBOTT MEDICAL OPTICS INC. (AMO)
Registered Establishment Number: 2020664
Owner/Operator Number: 1415939
Establishment Operations: Specification Developer; Complaint File Establishment