510(k) K840275
K840275 is an FDA 510(k) premarket notification submitted by Gary E. Hall, Dds for the device "CEHPALOMETRIC HEAD POSITIONER". The FDA issued a decision of Substantially Equivalent on March 16, 1984. The device falls under product code EAH (Cone, Radiographic, Lead-Lined), a Class I device regulated under 21 CFR 872.1850. Gary E. Hall, Dds has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 1984
- Date Received
- January 23, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cone, Radiographic, Lead-Lined
- Device Class
- Class I
- Regulation Number
- 872.1850
- Review Panel
- RA
- Submission Type