Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043725362

FEI Number

3043725362

Entity Name

OTOFLO LLC

City/State/Country

Louisville, KY, US

Establishment Address

400 E Main St Unit 102, Louisville, KY 40202, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

OtoFlo LLC (Owner Number: 10095471)

Owner / Operator Contact Address

400 E Main St, STE 102, Louisville, KY 40202, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OtoFlo, Pediatric OtoFlo, Adult

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2026-03-17

Official Correspondent

Grace Beebe

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OtoFlo LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043725362. Last updated year: 2026. Please use registration number 3043725362 when referencing this establishment in official correspondence.