The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Erika Heparin Infusion Adaptor.
Device ID | K810824 |
510k Number | K810824 |
Device Name: | ERIKA HEPARIN INFUSION ADAPTOR |
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 |