The following data is part of a premarket notification filed by International Medsurg Connection with the FDA for Imc Insulin Syringe.
Device ID | K110882 |
510k Number | K110882 |
Device Name: | IMC INSULIN SYRINGE |
Classification | Syringe, Piston |
Applicant | INTERNATIONAL MEDSURG CONNECTION 935 N. PLUM GROVE ROAD, SUITE F Schaumburg, IL 60173 |
Contact | Peter Kim |
Correspondent | Peter Kim INTERNATIONAL MEDSURG CONNECTION 935 N. PLUM GROVE ROAD, SUITE F Schaumburg, IL 60173 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-30 |
Decision Date | 2011-08-18 |
Summary: | summary |