The following data is part of a premarket notification filed by Delmed, Inc. with the FDA for Albumin Intravenous Administration Set.
Device ID | K791672 |
510k Number | K791672 |
Device Name: | ALBUMIN INTRAVENOUS ADMINISTRATION SET |
Classification | Set, Administration, Intravascular |
Applicant | DELMED, INC. (SENT TO BUREAU OF DRUGS) |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-28 |
Decision Date | 1979-10-26 |