510(k) K813378
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 1982
- Date Received
- December 1, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Holder, Film, X-Ray
- Device Class
- Class I
- Regulation Number
- 872.1905
- Review Panel
- DE
- Submission Type