510(k) K864527
K864527 is an FDA 510(k) premarket notification submitted by Gary E. Hall, Dds for the device "DUOCEPH". The FDA issued a decision of Substantially Equivalent on January 7, 1987. The device falls under product code IWY (Holder, Head, Radiographic), a Class I device regulated under 21 CFR 892.1920. Gary E. Hall, Dds has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 1987
- Date Received
- November 17, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Holder, Head, Radiographic
- Device Class
- Class I
- Regulation Number
- 892.1920
- Review Panel
- RA
- Submission Type