The following data is part of a premarket notification filed by Kawasumi Laboratories Co., Ltd. with the FDA for Kawasumi Laboratories Philebotomy Set.
| Device ID | K994323 |
| 510k Number | K994323 |
| Device Name: | KAWASUMI LABORATORIES PHILEBOTOMY SET |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | KAWASUMI LABORATORIES CO., LTD. 1900 K ST. N.W. Washington, DC 20006 |
| Contact | Donald R Stone |
| Correspondent | Donald R Stone KAWASUMI LABORATORIES CO., LTD. 1900 K ST. N.W. Washington, DC 20006 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-22 |
| Decision Date | 2000-03-08 |
| Summary: | summary |