510(k) K972966
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 1997
- Date Received
- August 11, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Collimator, Manual, Radiographic
- Device Class
- Class II
- Regulation Number
- 892.1610
- Review Panel
- RA
- Submission Type