510(k) K831173
K831173 is an FDA 510(k) premarket notification submitted by Erika, Inc. for the device "TORAY INDUSTRIES FILTRYZER HOLLOW FIBER". The FDA issued a decision of Substantially Equivalent on Jun 22, 1984. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), 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
- Jun 22, 1984
- Date Received
- Apr 11, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Accessories, Blood Circuit, Hemodialysis
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type
- 510(k)