510(k) K782064
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 28, 1978
- Date Received
- December 13, 1978
- 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