The following data is part of a premarket notification filed by Jiangsu Haize Medical Scientific Development Co.,ltd. with the FDA for Single Use Surgical Suction Irrigator.
| Device ID | K161421 |
| 510k Number | K161421 |
| Device Name: | Single Use Surgical Suction Irrigator |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | JIANGSU HAIZE MEDICAL SCIENTIFIC DEVELOPMENT CO.,LTD. NO.99, FURONGZHONGSAN RD, XISHAN ECONOMICAL DEVELOPMENT ZONE Wuxi, CN 214000 |
| Contact | Vivian Sun |
| Correspondent | Vivian Sun JIANGSU HAIZE MEDICAL SCIENTIFIC DEVELOPMENT CO.,LTD. NO.99, FURONGZHONGSAN RD, XISHAN ECONOMICAL DEVELOPMENT ZONE Wuxi, CN 214000 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-23 |
| Decision Date | 2016-06-24 |