The following data is part of a premarket notification filed by Hemcon Medical Technologies, Inc. with the FDA for Chitogauze, Models 130, 131, 263, 264, 265, 266.
| Device ID | K090026 |
| 510k Number | K090026 |
| Device Name: | CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266 |
| Classification | Dressing, Wound, Drug |
| Applicant | HEMCON MEDICAL TECHNOLOGIES, INC. 10575 SW CASCADE AVENUE SUITE 130 Portland, OR 97223 -4363 |
| Contact | Kevin Hawkins |
| Correspondent | Kevin Hawkins 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-05 |
| Decision Date | 2009-03-31 |
| Summary: | summary |