The following data is part of a premarket notification filed by Unimicro Medical Systems (shenzhen) Co.,ltd. with the FDA for Unimicro Veress Needle.
| Device ID | K150068 |
| 510k Number | K150068 |
| Device Name: | Unimicro Veress Needle |
| Classification | Insufflator, Laparoscopic |
| Applicant | Unimicro Medical Systems (ShenZhen) Co.,Ltd. 2/F, Bldg 31, The 3rd Industrial Area, Mashantou, Gongming Street, Guangming New District Shenzhen, CN 518106 |
| Contact | Weizhong Chen |
| Correspondent | Weizhong Chen Unimicro Medical Systems (ShenZhen) Co.,Ltd. 2/F, Bldg 31, The 3rd Industrial Area, Mashantou, Gongming Street, Guangming New District Shenzhen, CN 518106 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-13 |
| Decision Date | 2015-07-31 |
| Summary: | summary |