510(k) K851786
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 1985
- Date Received
- April 25, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Cast Application/Removal, Manual
- Device Class
- Class I
- Regulation Number
- 888.5980
- Review Panel
- OR
- Submission Type