ESI MANUFACTURING, LLC

FDA Device Registration & Listing · Gleason, WI, US · Registration 3013490757

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
3013490757
FEI Number
3013490757
Entity Name
ESI MANUFACTURING, LLC
City/State/Country
Gleason, WI, US
Establishment Address
W397 Doering Lane, Gleason, WI 54435, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
ESI Manufacturing, LLC (Owner Number: 10053737)
Owner / Operator Contact Address
W397 Doering Lane, Gleason, WI 54435, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
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
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2017-01-06

Official Correspondent

Jefford Larson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ESI Manufacturing, 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
K770926 Analytical Products, Inc. SUSPENSION SALINE, API 20E 1977-06-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013490757. Last updated year: 2026. Please use registration number 3013490757 when referencing this establishment in official correspondence.
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