FDA device listing

Alcon Surgical Procedure Packs

FDA device listing 1337186536 · Flextronics International USA, Inc.

Key facts

Proprietary names Alcon Surgical Procedure Packs
Owner/operator Flextronics International USA, Inc.
Owner/operator number 9006592
Product codes LRO
Device names LRO - General Surgery Tray
Device class Class II
Classification regulations (21 CFR) 878.4370
Review panels General & Plastic Surgery
Registered establishments Flextronics Manufacturing Juarez S. DE R.L. DE C.V.
Establishment registrations 3007344957
FEI numbers 3007344957
Establishment operations Contract 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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