510(k) K822711
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 1982
- Date Received
- September 7, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bougie, Urological
- Device Class
- Class I
- Regulation Number
- 876.5520
- Review Panel
- GU
- Submission Type