510(k) K801065
K801065 is an FDA 510(k) premarket notification submitted by Int'L Marketing & Sales Corp. for the device "NIKKISO PARALLEL FLOW DIALYZERS". The FDA issued a decision of Substantially Equivalent on August 7, 1980. The device falls under product code FTG (Illuminator, Remote), a Class II device regulated under 21 CFR 878.4580.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 1980
- Date Received
- May 6, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Illuminator, Remote
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type