The following data is part of a premarket notification filed by Hemcon Medical Technologies, Inc. with the FDA for Chitogauze Fusion.
| Device ID | K111163 |
| 510k Number | K111163 |
| Device Name: | CHITOGAUZE FUSION |
| Classification | Dressing, Wound, Drug |
| Applicant | HEMCON MEDICAL TECHNOLOGIES, INC. 10575 SW CASCADE AVENUE SUITE 130 Portland, OR 97223 -4363 |
| Contact | Kendra Rathkey |
| Correspondent | Kendra Rathkey HEMCON MEDICAL TECHNOLOGIES, INC. 10575 SW CASCADE AVENUE SUITE 130 Portland, OR 97223 -4363 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2011-04-26 |
| Decision Date | 2011-05-17 |
| Summary: | summary |