510(k) K873887
K873887 is an FDA 510(k) premarket notification submitted by W.R. Grace & Co.-Conn. for the device "MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL.". The FDA issued a decision of Substantially Equivalent on Dec 9, 1987. The device falls under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System), a Class II device regulated under 21 CFR 876.5860. W.R. Grace & Co.-Conn. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 9, 1987
- Date Received
- Sep 23, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device Class
- Class II
- Regulation Number
- 876.5860
- Review Panel
- GU
- Submission Type
- 510(k)