Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027553379

FEI Number

3027553379

Entity Name

EXCELENT

City/State/Country

Durham, NC, US

Establishment Address

68 TW Alexander Drive, PO BOX 13628, Research Triangle Park, Durham, NC 27709, US

Establishment Type(s)

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

Owner / Operator

EXCELENT (Owner Number: 10088310)

Owner / Operator Contact Address

68 TW Alexander Drive, PO BOX 13628, Research Triangle Park, Durham, NC 27709, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230258

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2023-06-27

Official Correspondent

Kashif Mazhar

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EXCELENT

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
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27

Similar Registrations

Registration Number	Establishment Name	Location
3027828125	MAJiK MEDICAL SOLUTIONS PRIVATE LIMITED	Hyderabad Telangana, IN
3005440795	XINHUA SURGICAL INSTRUMENT CO. LTD.	ZIBO Shandong, CN
2529846	MED SAVER, INC.	PHOENIXVILLE, PA, US
3003790304	GYRUS ACMI, INC.	Westborough, MA, US
9615857	INSTRUMENTARIUM SURGICAL CORP., INC.	TERREBONNE Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027553379. Last updated year: 2026. Please use registration number 3027553379 when referencing this establishment in official correspondence.