The following data is part of a premarket notification filed by Deka Research & Development Corp. with the FDA for Deka Solution Admin. Set Dk 302-a.
Device ID | K843054 |
510k Number | K843054 |
Device Name: | DEKA SOLUTION ADMIN. SET DK 302-A |
Classification | Set, Administration, Intravascular |
Applicant | DEKA RESEARCH & DEVELOPMENT CORP. 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 | 1984-08-03 |
Decision Date | 1984-09-13 |