The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Erika Negative Pressure Venous Bl Sets.
| Device ID | K792054 |
| 510k Number | K792054 |
| Device Name: | ERIKA NEGATIVE PRESSURE VENOUS BL SETS |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | ERIKA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-10-15 |
| Decision Date | 1979-12-06 |