The following data is part of a premarket notification filed by Lee Medical Intl., Inc. with the FDA for Sterile Disposable Needles.
Device ID | K832102 |
510k Number | K832102 |
Device Name: | STERILE DISPOSABLE NEEDLES |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | LEE MEDICAL INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-23 |
Decision Date | 1983-09-01 |