The following data is part of a premarket notification filed by Fresenius Medical Care Renal Therapies Group, Llc with the FDA for Crit-line Iii Blood Chamber Ii.
| Device ID | K160749 |
| 510k Number | K160749 |
| Device Name: | CRIT-LINE III Blood Chamber II |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC 920 WINTER STREET Waltham, MA 02451 |
| Contact | Denise Oppermann |
| Correspondent | Denise Oppermann FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC 920 WINTER STREET Waltham, MA 02451 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-18 |
| Decision Date | 2016-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840861102027 | K160749 | 000 |