510(k) K802478
K802478 is an FDA 510(k) premarket notification submitted by Cyberex Corp. for the device "CYBER 120 HEMODIALYZER". The FDA issued a decision of Substantially Equivalent on Mar 20, 1981. The device falls under product code FJG (Dialyzer, Parallel Flow), a Class II device regulated under 21 CFR 876.5820. Cyberex Corp. has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 20, 1981
- Date Received
- Oct 2, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Dialyzer, Parallel Flow
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type
- 510(k)