The following data is part of a premarket notification filed by Lifecore Biomedical, Inc. with the FDA for Calmatrix Calcium Sulfate Bone Graft Binder.
| Device ID | K041324 |
| 510k Number | K041324 |
| Device Name: | CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
| Contact | Kim E Aves |
| Correspondent | Kim E Aves LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-18 |
| Decision Date | 2004-07-19 |
| Summary: | summary |