The following data is part of a premarket notification filed by Aqua Sciences, Inc. with the FDA for Asi Deionizer & Carbon Exchange Service For Hemodialysis.
| Device ID | K102892 |
| 510k Number | K102892 |
| Device Name: | ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS |
| Classification | Subsystem, Water Purification |
| Applicant | AQUA SCIENCES, INC. 565 FILLMORE AVENUE Tonawanda, NY 14150 |
| Contact | Michael J Todd |
| Correspondent | Michael J Todd AQUA SCIENCES, INC. 565 FILLMORE AVENUE Tonawanda, NY 14150 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-30 |
| Decision Date | 2011-02-03 |
| Summary: | summary |