The following data is part of a premarket notification filed by Kawasumi Laboratories America, Inc. with the FDA for Iv Add-on Filter Administration Set With And Without Y Connect Or Needleless Access Connector.
| Device ID | K030385 |
| 510k Number | K030385 |
| Device Name: | IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR |
| 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 | 2003-02-05 |
| Decision Date | 2003-04-15 |
| Summary: | summary |