The following data is part of a premarket notification filed by Deka Research & Development Corp. with the FDA for Voyager Peritoneal Dialysis System.
| Device ID | K103220 |
| 510k Number | K103220 |
| Device Name: | VOYAGER PERITONEAL DIALYSIS SYSTEM |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | DEKA RESEARCH & DEVELOPMENT CORP. 340 COMMERCIAL ST. Manchester, NH 03101 |
| Contact | Roger A Leroux |
| Correspondent | Roger A Leroux DEKA RESEARCH & DEVELOPMENT CORP. 340 COMMERCIAL ST. Manchester, NH 03101 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-01 |
| Decision Date | 2011-07-29 |
| Summary: | summary |