The following data is part of a premarket notification filed by Isopure Corp. with the FDA for Isopure Complete Water System For Hemodialysis, Md 400 And Md 600 Series.
| Device ID | K041163 |
| 510k Number | K041163 |
| Device Name: | ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES |
| Classification | Subsystem, Water Purification |
| Applicant | ISOPURE CORP. 129 CITIZENS BLVD. Simpsonville, KY 40067 |
| Contact | Kevin Gillespie |
| Correspondent | Kevin Gillespie ISOPURE CORP. 129 CITIZENS BLVD. Simpsonville, KY 40067 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-03 |
| Decision Date | 2004-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852456007078 | K041163 | 000 |