POLO CUSTOM PRODUCTS

FDA Device Registration & Listing · Louisville, MS, US · Registration 3016704581

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016704581
FEI Number
3016704581
Entity Name
POLO CUSTOM PRODUCTS
City/State/Country
Louisville, MS, US
Establishment Address
15730 W Main Street, Louisville, MS 39339, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Polo Custom Products (Owner Number: 9919026)
Owner / Operator Contact Address
3601 SW 29th Street, --, Topeka, KS 66614, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Emergency Kit Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PXD Prep Kit General Hospital Class 1 880.6250 2022-12-21
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2023-12-04

Official Correspondent

Dawn Silver

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Polo Custom Products
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1927395 POLO CUSTOM PRODUCTS MONTICELLO, IA, US

Similar Registrations

Registration Number Establishment Name Location
1928237 MIDWEST STERILIZATION CORP. JACKSON, MO, US
1643817 ISOMEDIX OPERATIONS INC EL PASO, TX, US
3015876 PHYSIO-CONTROL, INC. Redmond, WA, US
9616088 Convertors de Mexico S. de R.L. de C.V CD.JUAREZ Chihuahua, MX
1061124 Sterigenics U.S., LLC Charlotte, NC, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016704581. Last updated year: 2026. Please use registration number 3016704581 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.