The following data is part of a premarket notification filed by Isopure Corp. with the FDA for Md 420/440/460/470/480/490.
| Device ID | K993200 |
| 510k Number | K993200 |
| Device Name: | MD 420/440/460/470/480/490 |
| Classification | Subsystem, Water Purification |
| Applicant | ISOPURE CORP. 11700 COMMONWEALTH DR. SUITE 605 Louisville, KY 40299 |
| Contact | Kevin C Gillespie |
| Correspondent | Kevin C Gillespie ISOPURE CORP. 11700 COMMONWEALTH DR. SUITE 605 Louisville, KY 40299 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-24 |
| Decision Date | 2000-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852456007054 | K993200 | 000 |
| 00852456007047 | K993200 | 000 |
| 00852456007030 | K993200 | 000 |
| 00852456007023 | K993200 | 000 |
| 00852456007016 | K993200 | 000 |
| 00852456007009 | K993200 | 000 |