The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Erika Art Li, 3-9621-8, 22-6, 23-4 & Ven 9714-1.
| Device ID | K852309 |
| 510k Number | K852309 |
| Device Name: | ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1 |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | ERIKA, INC. ONE ERIKA PLAZA Rockleigh, NJ 07647 |
| Contact | Del Donna |
| Correspondent | Del Donna ERIKA, INC. ONE ERIKA PLAZA Rockleigh, NJ 07647 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-29 |
| Decision Date | 1985-07-26 |