The following data is part of a premarket notification filed by International Medsurg Connection with the FDA for Imc Blood Collection Needle.
Device ID | K110656 |
510k Number | K110656 |
Device Name: | IMC BLOOD COLLECTION NEEDLE |
Classification | Needle, Hypodermic, Single Lumen |
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 | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-07 |
Decision Date | 2011-08-18 |
Summary: | summary |