The following data is part of a premarket notification filed by Shina Corp. with the FDA for Shina Insulin Syringe-including Accu-sure Insulin Syringes.
| Device ID | K091167 |
| 510k Number | K091167 |
| Device Name: | SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES |
| Classification | Syringe, Piston |
| Applicant | SHINA CORP. # 1005, OWNER'S TOWER 16-5, SUNAE-DONG, BUNDANG-GU Seongnam-si, Gyeonggi-do, KR |
| Contact | Yong Nam Shin |
| Correspondent | Yong Nam Shin SHINA CORP. # 1005, OWNER'S TOWER 16-5, SUNAE-DONG, BUNDANG-GU Seongnam-si, Gyeonggi-do, KR |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-22 |
| Decision Date | 2009-08-06 |
| Summary: | summary |