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 |