The following data is part of a premarket notification filed by Med-tech Water Systems Inc with the FDA for Med-tech Water Systems Inc Exchangeable Carbon Tanks For Dialysis.
| Device ID | K153329 |
| 510k Number | K153329 |
| Device Name: | MED-TECH Water Systems Inc Exchangeable Carbon Tanks For Dialysis |
| Classification | Subsystem, Water Purification |
| Applicant | MED-TECH WATER SYSTEMS INC 1755 WOOLNER AVENUE SUITE B Fairfield, CA 94533 |
| Contact | Brian C Kim |
| Correspondent | Brian C Kim MED-TECH WATER SYSTEMS INC 1755 WOOLNER AVENUE SUITE B Fairfield, CA 94533 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-19 |
| Decision Date | 2016-08-04 |
| Summary: | summary |