510(k) K902441
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- August 23, 1990
- Date Received
- June 1, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Surgical Instrument, Disposable
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type