510(k) K904279
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 1990
- Date Received
- September 17, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injector, Jet, Mechanical-Powered
- Device Class
- Class II
- Regulation Number
- 872.4475
- Review Panel
- DE
- Submission Type