The following data is part of a premarket notification filed by Kawasumi Laboratories, Inc. with the FDA for Kawasumi Laboratories Empty Solution Container.
Device ID | K061197 |
510k Number | K061197 |
Device Name: | KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER |
Classification | Container, I.v. |
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 | KPE |
CFR Regulation Number | 880.5025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-04-28 |
Decision Date | 2006-06-30 |
Summary: | summary |