The following data is part of a premarket notification filed by Kawasumi Laboratories, Inc. with the FDA for K-shield Port Access Infusion Set.
Device ID | K060580 |
510k Number | K060580 |
Device Name: | K-SHIELD PORT ACCESS INFUSION SET |
Classification | Set, Administration, Intravascular |
Applicant | KAWASUMI LABORATORIES, INC. 4723 OAK FAIR BLVD Tampa, FL 33610 |
Contact | Jack Pavlo |
Correspondent | Jack Pavlo KAWASUMI LABORATORIES, INC. 4723 OAK FAIR BLVD 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 | 2006-03-06 |
Decision Date | 2006-06-06 |
Summary: | summary |