FDA device listing

FD-504G-1(2.3.4.5.6.7.8.9) FD-501K-1(2.3.4.5.6.7.8.9) FD-502K-1(2.3.4.5.6.7.8.9)…

FDA device listing 1681101008 · Nanjing Yanan Special Lighting Factory

Key facts

Proprietary names FD-504G-1(2.3.4.5.6.7.8.9) FD-501K-1(2.3.4.5.6.7.8.9) FD-502K-1(2.3.4.5.6.7.8.9) FD-503K-1(2.3.4.5.6.7.8.9),FD-504K-1(2.3.4.5.6.7.8.9),Medical Magnifier FD-501G-1(2.3.4.5.6.7.8.9) FD-502G-1(2.3.4.5.6.7.8.9) FD-503G-1(2.3.4.5.6.7.8.9)
Owner/operator Nanjing Yanan Special Lighting Factory
Owner/operator number 10049430
Product codes FSP
Device names FSP - Loupe, Diagnostic/Surgical
Device class Class I
Classification regulations (21 CFR) 878.4800
Review panels General & Plastic Surgery
Registered establishments NANJING YANAN SPECIAL LIGHTING FACTORY
Establishment registrations 3011778089
FEI numbers 3011778089
Establishment operations Manufacturer
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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