The following data is part of a premarket notification filed by Sandstone Medical (suzhou) Inc. with the FDA for Easydrip Pen Needle, Easydrip Plus Pen Needle.
| Device ID | K193422 |
| 510k Number | K193422 |
| Device Name: | Easydrip Pen Needle, Easydrip Plus Pen Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Sandstone Medical (Suzhou) Inc. A601, Guangzhou International Business Incubator, Guangzhou Science Park Suzhou, CN 215301 |
| Contact | Juanjuan Sun |
| Correspondent | Elly Xu 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 | 2019-12-09 |
| Decision Date | 2021-02-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00894030002529 | K193422 | 000 |
| 36972857292974 | K193422 | 000 |
| 36972857292967 | K193422 | 000 |
| 36972857292950 | K193422 | 000 |
| 36972857292943 | K193422 | 000 |
| 36972857292936 | K193422 | 000 |
| 06972857292928 | K193422 | 000 |
| 36972857293193 | K193422 | 000 |
| 36972857293186 | K193422 | 000 |
| 36972857292981 | K193422 | 000 |
| 36972857292998 | K193422 | 000 |
| 00894030002130 | K193422 | 000 |
| 00894030002123 | K193422 | 000 |
| 00894030002116 | K193422 | 000 |
| 00894030002109 | K193422 | 000 |
| 00894030002055 | K193422 | 000 |
| 00894030002031 | K193422 | 000 |
| 06972857291914 | K193422 | 000 |
| 36972857293001 | K193422 | 000 |
| 36972857293179 | K193422 | 000 |