510(k) K910212
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 1991
- Date Received
- January 15, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Knife, Ear
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type