Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010892830

FEI Number

3010892830

Entity Name

NEPHRON SC, LLC.

City/State/Country

West Columbia, SC, US

Establishment Address

4500 12TH STREET EXT, West Columbia, SC 29172, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Nephron SC, LLC. (Owner Number: 10052964)

Owner / Operator Contact Address

4500 12th Street Ext., West Columbia, SC 29172, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K113033

PMA Number

N/A

All Registered Proprietary Names

Sodium Chloride Inhalation Solution, USP 3%, 7%, and 10% Sodium Chloride Inhalation Solution, USP 0.9%

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2016-10-20
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2016-10-20

Official Correspondent

Lou Kennedy

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nephron SC, LLC.

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
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07

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3005998497	SUNMED AP, LTD.	ZHUHAI Guangdong, CN
3006852037	Omron Healthcare Manufacturing Vietnam Co., Ltd.	Ho Chi Minh City, VN
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010892830. Last updated year: 2026. Please use registration number 3010892830 when referencing this establishment in official correspondence.