510(k) K884847
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 1989
- Date Received
- November 21, 1988
- 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