The following data is part of a premarket notification filed by Li-lien Corp. with the FDA for H.u. I.v. Drop Counter.
Device ID | K893693 |
510k Number | K893693 |
Device Name: | H.U. I.V. DROP COUNTER |
Classification | Monitor, Electric For Gravity Flow Infusion Systems |
Applicant | LI-LIEN CORP. C/O TRIDEC CORPORATION 1590 OLD OAKLAND RD. STE B 109 San Jose, CA 95131 |
Contact | Simon Fung |
Correspondent | Simon Fung LI-LIEN CORP. C/O TRIDEC CORPORATION 1590 OLD OAKLAND RD. STE B 109 San Jose, CA 95131 |
Product Code | FLN |
CFR Regulation Number | 880.2420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-16 |
Decision Date | 1989-10-27 |