The following data is part of a premarket notification filed by Shina Corp. with the FDA for Sterile Insulin Pen Needle.
| Device ID | K113186 |
| 510k Number | K113186 |
| Device Name: | STERILE INSULIN PEN NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SHINA CORP. 691-1, BOHEUNG-RI USEONG-MYEON, GONGJU-SI Chungchengnam-do, KR 314864 |
| Contact | Jiseop Jeong |
| Correspondent | Jiseop Jeong SHINA CORP. 691-1, BOHEUNG-RI USEONG-MYEON, GONGJU-SI Chungchengnam-do, KR 314864 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-28 |
| Decision Date | 2012-04-12 |
| Summary: | summary |