The following data is part of a premarket notification filed by Lifecore Biomedical, Inc. with the FDA for Hapset Hydroxylapatite Bone Graft Plaster.
| Device ID | K910432 |
| 510k Number | K910432 |
| Device Name: | HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | LIFECORE BIOMEDICAL, INC. 1050 CONNECTICUT AVENUE N.W. WASH. SQUARE SUITE 1100 Washington, DC 20036 |
| Contact | Bruce F Mackler |
| Correspondent | Bruce F Mackler LIFECORE BIOMEDICAL, INC. 1050 CONNECTICUT AVENUE N.W. WASH. SQUARE SUITE 1100 Washington, DC 20036 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-31 |
| Decision Date | 1991-05-01 |