The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Lifecare Empty Container.
Device ID | K771228 |
510k Number | K771228 |
Device Name: | LIFECARE EMPTY CONTAINER |
Classification | Container, I.v. |
Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
Product Code | KPE |
CFR Regulation Number | 880.5025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-07-07 |
Decision Date | 1977-08-02 |