The following data is part of a premarket notification filed by Warner-lambert Co. with the FDA for Deseret E-z Set Infusion Set.
Device ID | K821750 |
510k Number | K821750 |
Device Name: | DESERET E-Z SET INFUSION SET |
Classification | Set, Administration, Intravascular |
Applicant | WARNER-LAMBERT CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-15 |
Decision Date | 1982-07-02 |