510(k) K010712
K010712 is an FDA 510(k) premarket notification submitted by Molded Products, Inc. for the device "DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES". The FDA issued a decision of Substantially Equivalent on September 27, 2001. The device falls under product code FID (Tubing, Dialysate), a Class II device regulated under 21 CFR 876.5820. Molded Products, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 2001
- Date Received
- March 9, 2001
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubing, Dialysate
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type