The following data is part of a premarket notification filed by Sterilance Medical (suzhou) Inc. with the FDA for Insulin Pen Needle.
| Device ID | K153706 |
| 510k Number | K153706 |
| Device Name: | Insulin Pen Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | STERILANCE MEDICAL (SUZHOU) INC. 68 LITANGHE RD., XIANGCHENG Suzhou, CN 215113 |
| Contact | Juanjuan Sun |
| Correspondent | Field Fu SHENZHEN JOYANTECH CONSULTING CO., LTD. NO. 55 SHIZHOU MIDDLE ROAD, NANSHAN DISTRICT Shenzhen, CN Gd755 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-23 |
| Decision Date | 2016-08-29 |
| Summary: | summary |