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.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D767B0226101 | K080532 | 000 |
D767B0224101 | K080532 | 000 |
D767B0222101 | K080532 | 000 |
D767B0214101 | K080532 | 000 |
D767B0210101 | K080532 | 000 |
D767B0205101 | K080532 | 000 |