510(k) K961511
K961511 is an FDA 510(k) premarket notification submitted by Lifecore Biomedical, Inc. for the device "HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER". The FDA issued a decision of Substantially Equivalent on June 28, 1996. The device falls under product code LZK (Implant, Malar), a Class II device regulated under 21 CFR 878.3550. Lifecore Biomedical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 1996
- Date Received
- April 19, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Malar
- Device Class
- Class II
- Regulation Number
- 878.3550
- Review Panel
- SU
- Submission Type