The following data is part of a premarket notification filed by Sincere Medical Device Co., Ltd. with the FDA for 3s Safety Insulin Syringe.
| Device ID | K142436 |
| 510k Number | K142436 |
| Device Name: | 3S Safety Insulin Syringe |
| Classification | Syringe, Antistick |
| Applicant | Sincere Medical Device Co., Ltd. Rm 218, 2F., No.183, Zhouzi St. Taipei City, TW 114 |
| Contact | Garfield Wang |
| Correspondent | Garfield Wang Sincere Medical Device Co., Ltd. Rm 218, 2F., No.183, Zhouzi St. Taipei City, TW 114 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-29 |
| Decision Date | 2015-02-19 |
| Summary: | summary |