The following data is part of a premarket notification filed by Lifecore Biomedical with the FDA for Calforma Calcium Sulfate Bone Graft Barrier, Model 0.5g/1.0g.
| Device ID | K042730 |
| 510k Number | K042730 |
| Device Name: | CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | LIFECORE BIOMEDICAL 3515 LYMAN BLVD. Chaska, MN 55318 |
| Contact | Jeremy Huotari |
| Correspondent | Jeremy Huotari LIFECORE BIOMEDICAL 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 | 2004-10-01 |
| Decision Date | 2005-02-14 |
| Summary: | summary |