The following data is part of a premarket notification filed by Jiangsu Micsafe Medical Technology Co., Ltd with the FDA for Oral/enteral Syringe (10 Ml To 60 Ml) And Low Dose Tip Oral/enteral Syringe (1 Ml To 5 Ml).
| Device ID | K181426 |
| 510k Number | K181426 |
| Device Name: | Oral/Enteral Syringe (10 ML To 60 ML) And Low Dose Tip Oral/Enteral Syringe (1 ML To 5 ML) |
| Classification | Enteral Syringes With Enteral Specific Connectors |
| Applicant | Jiangsu Micsafe Medical Technology Co., Ltd Xituan Industrial Park, Dafeng District Yancheng, CN 224125 |
| Contact | Tony Yang |
| Correspondent | Helen Nan Wenzhou Cytech Information Service Co., Ltd. Room302, Building 3, Hangqian Street Lucheng District Wenzhou, CN 325000 |
| Product Code | PNR |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-31 |
| Decision Date | 2018-10-11 |
| Summary: | summary |