The following data is part of a premarket notification filed by Diabetic Supply Of Suncoast, Inc. with the FDA for Advocate Insulin Pen Needles.
| Device ID | K160199 |
| 510k Number | K160199 |
| Device Name: | Advocate Insulin Pen Needles |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Diabetic Supply Of Suncoast, Inc. Bo.Espinosa Carr.2km.26.2 Dorado, PR 00646 -9532 |
| Contact | Victoria Thuss |
| Correspondent | Matt Hedlund Matt Hedlund 3924 NE 157th PL Lake Forest Park, WA 98155 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-28 |
| Decision Date | 2016-10-19 |
| Summary: | summary |