The following data is part of a premarket notification filed by Simple Diagnostics, Inc. with the FDA for Comfort Ez.
| Device ID | K121632 |
| 510k Number | K121632 |
| Device Name: | COMFORT EZ |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SIMPLE DIAGNOSTICS, INC. 8870 RAVELLO CT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm SIMPLE DIAGNOSTICS, INC. 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 | 2012-06-04 |
| Decision Date | 2012-08-10 |
| Summary: | summary |