LogoFDA 510(k) Search
K Number
K080532
Device Name
BENACEL, MODELS C-001, C-002 AND C-005
Manufacturer
UNICARE BIOMEDICAL, INC.
Date Cleared
2008-11-12

(260 days)

Product Code
QSY
Regulation Number
N/A
Type
Traditional
Panel
General & Plastic Surgery
Reference & Predicate Devices
N/A
Predicate For
K140573
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA regarding an administrative change to a previous substantial equivalence determination for a device called "Benacel®".

This letter does not contain any information about:

  • Acceptance criteria for the device's performance.
  • Any study that proves the device meets acceptance criteria.
  • Details about sample sizes, data provenance, expert qualifications, ground truth, or study methodologies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

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

N/A