The following data is part of a premarket notification filed by Lee Medical Intl., Inc. with the FDA for Blood Tubing Set.
Device ID | K832103 |
510k Number | K832103 |
Device Name: | BLOOD TUBING SET |
Classification | Accessories, Blood Circuit, Hemodialysis |
Applicant | LEE MEDICAL INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KOC |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-23 |
Decision Date | 1983-08-12 |