The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Crit-line Clip (clic) Blood Chamber.
| Device ID | K152953 |
| 510k Number | K152953 |
| Device Name: | CRIT-LINE CLIP (CLIC) BLOOD CHAMBER |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA 920 Winter Street Waltham, MA 02451 -1457 |
| Contact | Denise Oppermann |
| Correspondent | Denise Oppermann FRESENIUS MEDICAL CARE NORTH AMERICA 920 Winter Street Waltham, MA 02451 -1457 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-07 |
| Decision Date | 2015-11-05 |
| Summary: | summary |