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 | K961511 |
| 510k Number | K961511 |
| Device Name: | HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER |
| Classification | Implant, Malar |
| Applicant | LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
| Contact | Lynn Cuperus |
| Correspondent | Lynn Cuperus LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska, MN 55318 |
| Product Code | LZK |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-19 |
| Decision Date | 1996-06-28 |
| Summary: | summary |