Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004743815

FEI Number

3004743815

Entity Name

ELITE CUSTOM SOLUTIONS

City/State/Country

Rochester, MN, US

Establishment Address

2450 Marion rd Se, Rochester, MN 55904, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Elite Custom Solutions (Owner Number: 10089531)

Owner / Operator Contact Address

2450 Marion rd Se, Rochester, MN 55904, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

5-Channel Anorectal Manometry Catheter Anorectal Balloon Expulsion Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KLA	Monitor, Esophageal Motility, Anorectal Motility, And Tube	Gastroenterology, Urology	Class 2	876.1725	2023-12-14

Official Correspondent

Samuel Prabhakar

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Elite Custom Solutions

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004743815. Last updated year: 2026. Please use registration number 3004743815 when referencing this establishment in official correspondence.