510(k) K050506
K050506 is an FDA 510(k) premarket notification submitted by Lifecore Biomedical, Inc. for the device "PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS". The FDA issued a decision of Substantially Equivalent on April 15, 2005. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Lifecore Biomedical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 15, 2005
- Date Received
- February 28, 2005
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type