510(k) K844364
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 2, 1985
- Date Received
- November 13, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rack, Skiascopic
- Device Class
- Class I
- Regulation Number
- 886.1750
- Review Panel
- OP
- Submission Type