The following data is part of a premarket notification filed by Lifemed Of California with the FDA for Low Volume Infustion Set.
Device ID | K821624 |
510k Number | K821624 |
Device Name: | LOW VOLUME INFUSTION SET |
Classification | Set, Administration, Intravascular |
Applicant | LIFEMED OF CALIFORNIA 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-02 |
Decision Date | 1982-06-22 |