BENACEL, MODELS C-001, C-002 AND C-005
Device Facts
| Record ID | K080532 |
|---|---|
| Device Name | BENACEL, MODELS C-001, C-002 AND C-005 |
| Applicant | Unicare Biomedical, Inc. |
| Product Code | QSY · SU |
| Decision Date | Nov 12, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Device Class | Class U |
Regulatory Classification
Identification
To temporarily control bleeding and cover external wounds.
Submission Summary (Full Text)
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July 28, 2023
Unicare Biomedical, Inc. c/o Stan Yang, Ph.D. Vice President 22971-B Triton Way Laguna Hills, California 92653
Re: K080532 Trade/Device Name: Benacel® Regulatory Class: Unclassified Product Code: QSY
Dear Stan Yang:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 12, 2008. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
> Sincerelv. Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
