The following data is part of a premarket notification filed by Kawasumi Laboratories America, Inc. with the FDA for Kawasumi Laboratories Iv Administration Set, Primary.
| Device ID | K001423 |
| 510k Number | K001423 |
| Device Name: | KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY |
| Classification | Set, Administration, Intravascular |
| Applicant | KAWASUMI LABORATORIES AMERICA, INC. 5905 C HAMPTON OAKS PKWY. Tampa, FL 33610 |
| Contact | Jack Pavlo |
| Correspondent | Jack Pavlo KAWASUMI LABORATORIES AMERICA, INC. 5905 C HAMPTON OAKS PKWY. Tampa, FL 33610 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-05 |
| Decision Date | 2000-07-21 |