The following data is part of a premarket notification filed by Advanced Renal Technologies, Inc. with the FDA for Dryalysate Concentrate.
| Device ID | K980659 |
| 510k Number | K980659 |
| Device Name: | DRYALYSATE CONCENTRATE |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | ADVANCED RENAL TECHNOLOGIES, INC. 2151 NORTH NORTHLAKE WAY, #200 Seattle, WA 98103 |
| Contact | Robin Callan |
| Correspondent | Robin Callan ADVANCED RENAL TECHNOLOGIES, INC. 2151 NORTH NORTHLAKE WAY, #200 Seattle, WA 98103 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-20 |
| Decision Date | 1998-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840861101467 | K980659 | 000 |
| 00840861101450 | K980659 | 000 |
| 00840861101443 | K980659 | 000 |
| 00840861101436 | K980659 | 000 |
| 00840861101429 | K980659 | 000 |
| 00840861101412 | K980659 | 000 |
| 00840861101405 | K980659 | 000 |
| 00840861101399 | K980659 | 000 |