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 |