FDA device listing

Frame, spectacle

FDA device listing 1763205595 · GANOE INC

Key facts

Proprietary names Frame, spectacle
Owner/operator GANOE INC
Owner/operator number 10092812
Product codes HQZ
Device names HQZ - Frame, Spectacle
Device class Class I
Classification regulations (21 CFR) 886.5842
Review panels Ophthalmic
Registered establishments GANOE INC
Establishment registrations 3031710707
FEI numbers 3031710707
Establishment operations Repackager/Relabeler
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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