The following data is part of a premarket notification filed by Delmed, Inc. with the FDA for Delmed Iv Container.
Device ID | K830450 |
510k Number | K830450 |
Device Name: | DELMED IV CONTAINER |
Classification | Container, I.v. |
Applicant | DELMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KPE |
CFR Regulation Number | 880.5025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-02-15 |
Decision Date | 1983-03-01 |