The following data is part of a premarket notification filed by Home Dialysis Plus with the FDA for Tablo Cartridge.
| Device ID | K140841 |
| 510k Number | K140841 |
| Device Name: | TABLO CARTRIDGE |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | HOME DIALYSIS PLUS 257 HUMBOLDT COURT Sunnyvale, CA 94089 |
| Contact | Nancy Gallo |
| Correspondent | Nancy Gallo HOME DIALYSIS PLUS 257 HUMBOLDT COURT Sunnyvale, CA 94089 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-02 |
| Decision Date | 2014-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850001011143 | K140841 | 000 |
| 00850001011082 | K140841 | 000 |
| 10850001011072 | K140841 | 000 |
| 00850001011013 | K140841 | 000 |