510(k) K870626
K870626 is an FDA 510(k) premarket notification submitted by Delmed, Inc. for the device "FREEDOM SET II WITH TRIFLEX VALVE". The FDA issued a decision of Substantially Equivalent on June 3, 1987. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. Delmed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 1987
- Date Received
- February 13, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, For Peritoneal Dialysis, Disposable
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type