510(k) K982413
K982413 is an FDA 510(k) premarket notification submitted by Gambro Healthcare for the device "COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS". The FDA issued a decision of Substantially Equivalent on April 21, 1999. 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. Gambro Healthcare has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1999
- Date Received
- July 13, 1998
- 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