510(k) K895738
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 1989
- Date Received
- September 26, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bur, Ear, Nose And Throat
- Device Class
- Class I
- Regulation Number
- 874.4140
- Review Panel
- EN
- Submission Type