510(k) K852894
K852894 is an FDA 510(k) premarket notification submitted by Ormco Corp. for the device "ORMCO TRANSMANDIBULAR IMPLANT". The FDA issued a decision of SESP on August 29, 1985. The device falls under product code MDL (Implant, Transmandibular), a Class II device regulated under 21 CFR 872.4760. Ormco Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESP ()
- Decision Date
- August 29, 1985
- Date Received
- July 9, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Transmandibular
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type