The following data is part of a premarket notification filed by Kawasumi Laboratories, Inc. with the FDA for K-shield Port Access Infusion Set With High Pressure Tubing.
| Device ID | K100720 |
| 510k Number | K100720 |
| Device Name: | K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING |
| Classification | Set, Administration, Intravascular |
| Applicant | KAWASUMI LABORATORIES, INC. 1601 K STREET, N.W. Washington, DC 20006 |
| Contact | Suzan Onel |
| Correspondent | Suzan Onel KAWASUMI LABORATORIES, INC. 1601 K STREET, N.W. Washington, DC 20006 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-15 |
| Decision Date | 2010-11-18 |
| Summary: | summary |