The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Fresenius Sterile Stay Safe Cap.
| Device ID | K083542 |
| 510k Number | K083542 |
| Device Name: | FRESENIUS STERILE STAY SAFE CAP |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA 920 Winter Street Waltham, MA 02451 -1457 |
| Contact | Janet Kay |
| Correspondent | Janet Kay FRESENIUS MEDICAL CARE NORTH AMERICA 920 Winter Street Waltham, MA 02451 -1457 |
| Product Code | KDJ |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-28 |
| Decision Date | 2008-12-29 |
| Summary: | summary |