510(k) K853005
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 1985
- Date Received
- July 16, 1985
- 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