510(k) K170913
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 2017
- Date Received
- March 28, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Splint, Intranasal Septal
- Device Class
- Class I
- Regulation Number
- 874.4780
- Review Panel
- EN
- Submission Type