Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007788086

FEI Number

3007788086

Entity Name

CHITOGEN INC

City/State/Country

Maple Grove, MN, US

Establishment Address

10200 73rd Ave N Ste 120, Maple Grove, MN 55369, US

Establishment Type(s)

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

Owner / Operator

Chitogen Inc (Owner Number: 10029008)

Owner / Operator Contact Address

12805 HWY 55, Suite 202, Plymouth, MN 55441, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K112864

PMA Number

N/A

All Registered Proprietary Names

SoftSeal-STF D-Seal SoftSeal-STFR SoftSeal-C

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2009-03-27
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2009-03-27
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2013-02-02

Official Correspondent

Steve Muellerleile

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Chitogen Inc

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
K220566	Koag, LLC	Vascette HP (hemostatic pad)	2022-07-29
K080818	Hem Con Medical Technologies, Inc.	HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING	2008-05-15
K893123	Les Laboratorires Brothier, S.A.	ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES	1990-02-13
K143462	Benq Materials Corporation	AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)	2015-05-08
K040208	Tz Medical, Inc.	NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND	2004-05-11

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007788086. Last updated year: 2026. Please use registration number 3007788086 when referencing this establishment in official correspondence.