510(k) K953457
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 1995
- Date Received
- July 21, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Examining/Treatment, Ent
- Device Class
- Class I
- Regulation Number
- 874.5300
- Review Panel
- EN
- Submission Type