510(k) K771986
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 1977
- Date Received
- October 19, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Evacuator, Fluid
- Device Class
- Class II
- Regulation Number
- 876.4370
- Review Panel
- GU
- Submission Type