510(k) K810683
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 1981
- Date Received
- March 13, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Peritoneal, Automatic Delivery
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type