FDA device listing

Diabetic Wound Therapy

FDA device listing 1686424701 · Lavior Pharma Inc.

Key facts

Proprietary names Diabetic Wound Therapy
Owner/operator Lavior Pharma Inc.
Owner/operator number 10086490
Product codes FRO
Device names FRO - Dressing, Wound, Drug
Device class Unclassified
Classification regulations (21 CFR) ORCA1.FRO
Review panels General & Plastic Surgery
Registered establishments LAVIOR PHARMA INC.
Establishment registrations 3022133572
FEI numbers 3022133572
Establishment operations U.S. Manufacturer of Export Only Devices
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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