510(k) K771732
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 1977
- Date Received
- September 15, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Continuous Irrigation
- Device Class
- Class I
- Regulation Number
- 878.4200
- Review Panel
- SU
- Submission Type