The following data is part of a premarket notification filed by International Medsurg Connection with the FDA for Imc Hypodermic Needle.
| Device ID | K102584 |
| 510k Number | K102584 |
| Device Name: | IMC HYPODERMIC NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | INTERNATIONAL MEDSURG CONNECTION 935 N PLUM GROVE RD., STE F Schaumburg, IL 60173 |
| Contact | Peter Kim |
| Correspondent | Peter Kim INTERNATIONAL MEDSURG CONNECTION 935 N PLUM GROVE RD., STE 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 | 2010-09-08 |
| Decision Date | 2011-01-14 |