The following data is part of a premarket notification filed by Unicare Biomedical with the FDA for Unigraft.
Device ID | K993784 |
510k Number | K993784 |
Device Name: | UNIGRAFT |
Classification | Bone Grafting Material, Synthetic |
Applicant | UNICARE BIOMEDICAL 25951 LA CUESTA AVE. Laguna Hills, CA 92653 |
Contact | Stan Yang |
Correspondent | Stan Yang UNICARE BIOMEDICAL 25951 LA CUESTA AVE. Laguna Hills, CA 92653 |
Product Code | LYC |
CFR Regulation Number | 872.3930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-11-08 |
Decision Date | 2000-01-27 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
UNIGRAFT 75710295 2407291 Live/Registered |
Unicare Biomedical, Inc. 1999-06-15 |