510(k) K850654
K850654 is an FDA 510(k) premarket notification submitted by Erika, Inc. for the device "TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID". The FDA issued a decision of Substantially Equivalent on Mar 7, 1985. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Erika, Inc. has 42 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 7, 1985
- Date Received
- Feb 19, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Dialyzer, Capillary, Hollow Fiber
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type
- 510(k)