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 |