510(k) K822857
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 8, 1983
- Date Received
- September 27, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Holder, Speculum, Ent
- Device Class
- Class I
- Regulation Number
- 878.1800
- Review Panel
- SU
- Submission Type