BENACEL, MODELS C-001, C-002 AND C-005

Dressing, Wound, Drug

UNICARE BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Unicare Biomedical, Inc. with the FDA for Benacel, Models C-001, C-002 And C-005.

Pre-market Notification Details

• Device ID: K080532
• 510k Number: K080532
• Device Name: BENACEL, MODELS C-001, C-002 AND C-005
• Classification: Dressing, Wound, Drug
• Applicant: UNICARE BIOMEDICAL, INC. 22971-B TRITON WAY Laguna Hills, CA 92653
• Contact: Stan Yang
• Correspondent: Stan Yang; UNICARE BIOMEDICAL, INC. 22971-B TRITON WAY Laguna Hills, CA 92653
• Product Code: FRO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-02-26
• Decision Date: 2008-11-12
• Summary: summary