Data / Medical devices / United States / Chitogen Inc
Chitogen Inc: FDA-registered device maker in Maple Grove, MN, United States, 2 510(k) clearances
Chitogen Inc is registered with the FDA (registration 3007788086) in Maple Grove, MN, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 2, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007788086
- Address
- 10200 73rd Ave N Ste 120, Maple Grove, MN, United States, 55369
- Owner or operator
- Chitogen Inc (10029008)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 27, 2009
- Registered through
- 2026
- Brand names listed
- D-Seal, SoftSeal-C, SoftSeal-STF, SoftSeal-STFR
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | U | Manufacturer, Specification developer | accessdata.fda.gov |
| Splint, Intranasal Septal | LYA | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 2, 2012 | K112864 | SOFTSEAL-C | QSY | Substantially Equivalent | Chitogen, Inc. | accessdata.fda.gov |
| March 11, 2009 | K090100 | SOFTSEAL-STF | QSY | Substantially Equivalent | Chitogen, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Hemostatic Wound Dressing Without Thrombin Or Other Biologics
- All makers of Splint, Intranasal Septal
Updated August 2, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.