510(k) K862716
K862716 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "HEMOFILTRATION SYSTEM 10". The FDA issued a decision of Substantially Equivalent on September 9, 1986. The device falls under product code FII (System, Dialysate Delivery, Sealed), a Class II device regulated under 21 CFR 876.5860. Gambro, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 1986
- Date Received
- July 17, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Dialysate Delivery, Sealed
- Device Class
- Class II
- Regulation Number
- 876.5860
- Review Panel
- GU
- Submission Type