The following data is part of a premarket notification filed by Kawasumi Laboratories, Inc. with the FDA for K-shield Advantage Port Access Infusion Set (pais).
Device ID | K123344 |
510k Number | K123344 |
Device Name: | K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS) |
Classification | Set, Administration, Intravascular |
Applicant | KAWASUMI LABORATORIES, INC. 7401 104TH AVE. STE 160 Kenosha, WI 53142 |
Contact | Christina Henza |
Correspondent | Christina Henza KAWASUMI LABORATORIES, INC. 7401 104TH AVE. STE 160 Kenosha, WI 53142 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-10-31 |
Decision Date | 2013-03-07 |
Summary: | summary |