The following data is part of a premarket notification filed by Lee Medical Intl., Inc. with the FDA for Sterile Insulin Dispos. Needle/green.
Device ID | K840083 |
510k Number | K840083 |
Device Name: | STERILE INSULIN DISPOS. NEEDLE/GREEN |
Classification | Syringe, Piston |
Applicant | LEE MEDICAL INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-10 |
Decision Date | 1984-02-21 |