The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Erika Extension Sets.
| Device ID | K810823 |
| 510k Number | K810823 |
| Device Name: | ERIKA EXTENSION SETS |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | ERIKA, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-24 |
| Decision Date | 1981-04-17 |