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 |