The following data is part of a premarket notification filed by Hemcon Medical Technologies, Inc. with the FDA for Chitogauze.
| Device ID | K102546 |
| 510k Number | K102546 |
| Device Name: | CHITOGAUZE |
| 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 | No |
| Date Received | 2010-09-03 |
| Decision Date | 2010-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50870053000136 | K102546 | 000 |
| 50870053000013 | K102546 | 000 |
| 50870053000310 | K102546 | 000 |
| 20870053000562 | K102546 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CHITOGAUZE 77611455 3825898 Live/Registered |
TRICOL BIOMEDICAL, INC. 2008-11-10 |