The following data is part of a premarket notification filed by Currie Medical Specialties, Inc. with the FDA for Cms 2000 Series Tpn Kits.
Device ID | K831964 |
510k Number | K831964 |
Device Name: | CMS 2000 SERIES TPN KITS |
Classification | Patient Examination Glove |
Applicant | CURRIE MEDICAL SPECIALTIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FMC |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-17 |
Decision Date | 1983-08-11 |