510(k) K954200
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 1995
- Date Received
- September 6, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Film, Radiographic
- Device Class
- Class I
- Regulation Number
- 892.1840
- Review Panel
- RA
- Submission Type