The following data is part of a premarket notification filed by Mhc Medical Products, Llc. with the FDA for Easytouch Safety Pen Needle.
| Device ID | K163578 |
| 510k Number | K163578 |
| Device Name: | EasyTouch Safety Pen Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MHC Medical Products, LLC. 8695 Seward Road Fairfield, OH 45011 |
| Contact | John Edmiston |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct. Naples, FL 34114 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-20 |
| Decision Date | 2018-08-03 |
| Summary: | summary |