The following data is part of a premarket notification filed by Molded Products Inc. with the FDA for Dialysate Line With Connectors/re-use Wash-out Lines.
| Device ID | K010712 |
| 510k Number | K010712 |
| Device Name: | DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES |
| Classification | Tubing, Dialysate |
| Applicant | MOLDED PRODUCTS INC. 601 DURANT ST. Harlan, IA 51537 |
| Contact | Elise Johnston |
| Correspondent | Elise Johnston MOLDED PRODUCTS INC. 601 DURANT ST. Harlan, IA 51537 |
| Product Code | FID |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-09 |
| Decision Date | 2001-09-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B144MPC6603 | K010712 | 000 |
| B144MPC1451 | K010712 | 000 |