Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004183512

FEI Number

3004183512

Entity Name

KL DISTRIBUTING

City/State/Country

Hudson, FL, US

Establishment Address

7425 Sailfish Dr, Hudson, FL 34667, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KL DISTRIBUTING (Owner Number: 9056236)

Owner / Operator Contact Address

16034 us hwy 19, --, Hudson, FL 34667, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K173528

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
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2021-08-31
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2021-08-31
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2023-04-13
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2021-08-31
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2021-08-31

Official Correspondent

MARK JULIAN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KL DISTRIBUTING

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
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04

Similar Registrations

Registration Number	Establishment Name	Location
3033981998	KOYA MEDICAL, INC.	Dallas, TX, US
3020703724	Therma Bright Inc.	Toronto Ontario, CA
3014491159	AIROS MEDICAL INC	Audubon, PA, US
3014834638	ZENITH TECHNICAL INNOVATIONS, LLC	Gurnee, IL, US
3009155917	GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004183512. Last updated year: 2026. Please use registration number 3004183512 when referencing this establishment in official correspondence.