Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016609920

FEI Number

3016609920

Entity Name

VALENSIL

City/State/Country

Avon, OH, US

Establishment Address

34910 Commerce Way, Avon, OH 44011, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Valensil (Owner Number: 10062875)

Owner / Operator Contact Address

34910 Commerce Way, Avon, OH 44011, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191728

PMA Number

N/A

All Registered Proprietary Names

ULTepap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OHP	Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea	Dental	Class 2	872.5570	2020-03-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Valensil

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 3016609920. Last updated year: 2026. Please use registration number 3016609920 when referencing this establishment in official correspondence.