510(k) K801208
K801208 is an FDA 510(k) premarket notification submitted by Colmed, Ltd. for the device "HOLLOW BASKET TITANIUM DENTAL IMPLANT". The FDA issued a decision of Substantially Equivalent on May 28, 1980. The device falls under product code ELE (Implant, Subperiosteal), a Class II device regulated under 21 CFR 872.3645. Colmed, Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 1980
- Date Received
- May 20, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Subperiosteal
- Device Class
- Class II
- Regulation Number
- 872.3645
- Review Panel
- DE
- Submission Type