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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Acesight; Acesight S; Acesight VR
Classification Name: SPECTACLE, MAGNIFYING
Product Code: HOI
Device Class: 1
Regulation Number: 886.5840
Medical Specialty: Ophthalmic
Registered Establishment Name: ZOOMAX (USA) INC.
Registered Establishment Number: 3014656174
Owner/Operator: Zoomax (USA) Inc.
Owner/Operator Number: 10058885
Establishment Operations: Repackager/Relabeler
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