CYTOFLEX
Bone Grafting Material, Synthetic
UNICARE BIOMEDICAL, INC.
The following data is part of a premarket notification filed by Unicare Biomedical, Inc. with the FDA for Cytoflex.
Pre-market Notification Details
| Device ID | K012144 |
| 510k Number | K012144 |
| Device Name: | CYTOFLEX |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | UNICARE BIOMEDICAL, INC. 25951 LA CUESTA AVE. Laguna Hills, CA 92653 |
| Contact | Stan Yang |
| Correspondent | Stan Yang UNICARE BIOMEDICAL, INC. 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 | 2001-07-10 |
| Decision Date | 2001-10-01 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D767C0402010 | K012144 | 000 |
| D767C0401051 | K012144 | 000 |
| D767C0103051 | K012144 | 000 |
| D767C0101051 | K012144 | 000 |
| D767C0802010 | K012144 | 000 |
| D767C0801010 | K012144 | 000 |
Trademark Results [CYTOFLEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CYTOFLEX 97482211 not registered Live/Pending |
Meissner Filtration Products, Inc. 2022-06-29 |
 CYTOFLEX 97083380 not registered Live/Pending |
Beckman Coulter, Inc. 2021-10-20 |
 CYTOFLEX 87173445 not registered Dead/Abandoned |
Orthogistic LLC 2016-09-16 |
 CYTOFLEX 87117373 not registered Dead/Abandoned |
Broderick, Thomas C 2016-07-27 |
 CYTOFLEX 87038257 5105035 Live/Registered |
BECKMAN COULTER, INC. 2016-05-16 |
 CYTOFLEX 85193369 4192684 Live/Registered |
Unicare Biomedical, Inc. 2010-12-08 |
 CYTOFLEX 78723549 3403145 Dead/Cancelled |
Cytosport, Inc. 2005-09-29 |
 CYTOFLEX 78072607 2647353 Dead/Cancelled |
Unicare biomedical, Inc. 2001-07-06 |
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