Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017927175

FEI Number

3017927175

Entity Name

NEWSOM

City/State/Country

Paris, FR

Establishment Address

15 rue de bruxelles, Paris 75009, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NEWSOM (Owner Number: 10079990)

Owner / Operator Contact Address

15 rue de bruxelles, Paris, FR-75 75009, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162192

PMA Number

N/A

All Registered Proprietary Names

BluePro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2021-01-06

Official Correspondent

Erwan Floch

US Agent Details

Matthew Dryden Business: ProMedic, LLC Email: matt.dryden@promedic.cc Phone: (239) 3076063

Related Public Records

Same Entity

NEWSOM

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10

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3007108578	TRUE FUNCTION LABORATORY INC	La Mesa, CA, US
3006786034	Innovative Health Technologies (NZ) Limited	Dunedin Otago, NZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017927175. Last updated year: 2026. Please use registration number 3017927175 when referencing this establishment in official correspondence.