BENACEL
Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
UNICARE BIOMEDICAL
The following data is part of a premarket notification filed by Unicare Biomedical with the FDA for Benacel.
Pre-market Notification Details
| Device ID | K090612 |
| 510k Number | K090612 |
| Device Name: | BENACEL |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | UNICARE BIOMEDICAL 22971 TRITON WAY Laguna Hills, CA 92653 |
| Contact | Stan Yang |
| Correspondent | Stan Yang UNICARE BIOMEDICAL 22971 TRITON WAY Laguna Hills, CA 92653 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-06 |
| Decision Date | 2009-07-24 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D767B0105101 | K090612 | 000 |
| D767B0103081 | K090612 | 000 |
| D767B0102121 | K090612 | 000 |
| D767B0101081 | K090612 | 000 |
| D767B0105081 | K090612 | 000 |
Trademark Results [BENACEL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BENACEL 77044125 3284897 Live/Registered |
Unicare Biomedical, Inc. 2006-11-15 |
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