510(k) K803068
K803068 is an FDA 510(k) premarket notification submitted by NIKKISO CO., LTD. for the device "NIKKISO ND-14 PARALLEL FLOW DIALYZER". The FDA issued a decision of Substantially Equivalent on March 4, 1981. The device falls under product code FJG (Dialyzer, Parallel Flow), a Class II device regulated under 21 CFR 876.5820. NIKKISO CO., LTD. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 1981
- Date Received
- December 4, 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