FDA device listing

Hood Nasal Septal Button

FDA device listing 2007305272 · Critical Care Diagnostics, Inc

Key facts

Proprietary names Hood Nasal Septal Button
Owner/operator Critical Care Diagnostics, Inc
Owner/operator number 10059775
Premarket submissions K920994
Product codes LFB
Device names LFB - Button, Nasal Septal
Device class Unclassified
Classification regulations (21 CFR) ORCA1.LFB
Review panels Ear, Nose, & Throat
Registered establishments E. Benson Hood Laboratories, Inc.
Establishment registrations 1220850
FEI numbers 1220850
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes 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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