The following data is part of a premarket notification filed by Masters Healthcare, Llc. with the FDA for Easy.touch Insulin Syringe.
| Device ID | K091474 |
| 510k Number | K091474 |
| Device Name: | EASY.TOUCH INSULIN SYRINGE |
| Classification | Syringe, Piston |
| Applicant | MASTERS HEALTHCARE, LLC. 333 MILFORD RD. Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm MASTERS HEALTHCARE, LLC. 333 MILFORD RD. Deerfield, IL 60015 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-18 |
| Decision Date | 2009-07-09 |
| Summary: | summary |