510(k) K800666
K800666 is an FDA 510(k) premarket notification submitted by Liquid Crystal Products, Inc. for the device "QUIK-TEMP". The FDA issued a decision of Substantially Equivalent on May 8, 1980. The device falls under product code KPP (Peritoneal Dialysate Filter), a Class II device regulated under 21 CFR 876.5630. Liquid Crystal Products, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 1980
- Date Received
- March 26, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Peritoneal Dialysate Filter
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type