510(k) K830189
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 1983
- Date Received
- January 19, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Blade, Saw, Surgical, Cardiovascular
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type