510(k) K963326
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 1997
- Date Received
- August 23, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Nasal
- Device Class
- Class I
- Regulation Number
- 874.3900
- Review Panel
- EN
- Submission Type