510(k) K870243
K870243 is an FDA 510(k) premarket notification submitted by Medrad, Inc. for the device "BURNETT TMJ APPLIANCE". The FDA issued a decision of Substantially Equivalent on February 24, 1987. The device falls under product code EAG (Cephalometer), a Class II device regulated under 21 CFR 872.1830. Medrad, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 1987
- Date Received
- January 21, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cephalometer
- Device Class
- Class II
- Regulation Number
- 872.1830
- Review Panel
- RA
- Submission Type