Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010521015

FEI Number

3010521015

Entity Name

FISTULA SOLUTION CORPORATION

City/State/Country

Scandia, MN, US

Establishment Address

10604 230TH ST N, Scandia, MN 55073, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Fistula Solution Corporation (Owner Number: 10045153)

Owner / Operator Contact Address

10604 230th Street North, Scandia, MN 55073, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wound Crown Isolator Strip Fistula Funnel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EZS	Appliance, Colostomy, Disposable	Gastroenterology, Urology	Class 1	876.5900	2013-10-23

Official Correspondent

Andrew Obst

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Fistula Solution Corporation

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3007311035	Colo-Majic Enterprises LTD	Maple Ridge British Columbia, CA
3013863160	HUBEI HENDRY MEDICAL APPLIANCE CO., LTD	Xiaogan City Hubei, CN
9617198	SALTS HEALTHCARE LIMITED	ASTON BIRMINGHAM, GB
3019682549	VERSIPEL, LLC	Dunmore, PA, US
3011987967	ConvaTec, Inc.	Greensboro, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010521015. Last updated year: 2026. Please use registration number 3010521015 when referencing this establishment in official correspondence.