The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Lazarus-nelson Peritoneal Lavage Tray.
| Device ID | K813336 |
| 510k Number | K813336 |
| Device Name: | LAZARUS-NELSON PERITONEAL LAVAGE TRAY |
| Classification | Catheter, Peritoneal Dialysis, Single Use |
| Applicant | AMERICAN PHARMASEAL DIV. AHSC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKO |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-24 |
| Decision Date | 1981-12-18 |