The following data is part of a premarket notification filed by Sandstone Medical (suzhou) Inc. with the FDA for Safety Pen Needle.
| Device ID | K210864 |
| 510k Number | K210864 |
| Device Name: | Safety Pen Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Sandstone Medical (Suzhou) Inc. No.168 PuTuoShan Road, New District Suzhou, CN 215153 |
| Contact | Juanjuan Sun |
| Correspondent | Grace Liu Shenzhen Joyantech Consulting Co., Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, CN 518000 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-23 |
| Decision Date | 2022-02-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00373317000064 | K210864 | 000 |
| 36972857291236 | K210864 | 000 |
| 06972857291785 | K210864 | 000 |
| 36972857292561 | K210864 | 000 |
| 00810008212080 | K210864 | 000 |
| 36972857293025 | K210864 | 000 |
| 36972857293018 | K210864 | 000 |