GUARDACARE
Dressing, Wound, Drug
HEMCON MEDICAL TECHNOLOGIES, INC.
The following data is part of a premarket notification filed by Hemcon Medical Technologies, Inc. with the FDA for Guardacare.
Pre-market Notification Details
| Device ID | K103641 |
| 510k Number | K103641 |
| Device Name: | GUARDACARE |
| 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 | Yes |
| Date Received | 2010-12-13 |
| Decision Date | 2011-06-16 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00870053000117 | K103641 | 000 |
Trademark Results [GUARDACARE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GUARDACARE 77856516 3915050 Live/Registered |
TRICOL BIOMEDICAL, INC. 2009-10-23 |
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