The following data is part of a premarket notification filed by Hemcon Medical Technologies Europe, Ltd. with the FDA for Hemcon Hemostatic Gel.
| Device ID | K112215 |
| 510k Number | K112215 |
| Device Name: | HEMCON HEMOSTATIC GEL |
| Classification | Dressing, Wound, Drug |
| Applicant | HEMCON MEDICAL TECHNOLOGIES EUROPE, LTD. 10575 SW CASCADE AVENUE, SUITE 130 Portland, OR |
| Contact | Kendra Rathkey |
| Correspondent | Kendra Rathkey HEMCON MEDICAL TECHNOLOGIES EUROPE, LTD. 10575 SW CASCADE AVENUE, SUITE 130 Portland, OR |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-02 |
| Decision Date | 2012-04-12 |
| Summary: | summary |