The following data is part of a premarket notification filed by Unicare Biomedical, Inc. with the FDA for Cytoflex Resorb, Model C03-0010 Through C03-090.
Device ID | K090083 |
510k Number | K090083 |
Device Name: | CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 |
Classification | Bone Grafting Material, Synthetic |
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 | LYC |
CFR Regulation Number | 872.3930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-01-12 |
Decision Date | 2009-03-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D767C0303010 | K090083 | 000 |
D767C0302010 | K090083 | 000 |
D767C0301010 | K090083 | 000 |