The following data is part of a premarket notification filed by Medical Technomics, Ltd. with the FDA for Ringcaps.
Device ID | K843362 |
510k Number | K843362 |
Device Name: | RINGCAPS |
Classification | Tube, Collection, Capillary Blood |
Applicant | MEDICAL TECHNOMICS, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GIO |
CFR Regulation Number | 864.6150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-28 |
Decision Date | 1984-09-21 |