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 |