The following data is part of a premarket notification filed by Unimicro Medical Systems (shenzhen) Co., Ltd. with the FDA for Monopolar Laparascopic Accessories.
| Device ID | K142208 |
| 510k Number | K142208 |
| Device Name: | Monopolar Laparascopic Accessories |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD. 2/F,Bldg31,3rd Industrial Area,Mashantou Guangming St.,Guangming New District Shenzhen, CN 518106 |
| Contact | Weizhong Chen |
| Correspondent | Long Yang Shenzen Hlongmed Biotech Co., Ltd R15-08, East Building, Yihai Plaza, Chuangye Road, Nanshan D Shenzhen, CN 518054 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-11 |
| Decision Date | 2015-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810143450781 | K142208 | 000 |
| 00810143451221 | K142208 | 000 |
| 00810143451214 | K142208 | 000 |
| 00810143451207 | K142208 | 000 |
| B382SD3969890 | K142208 | 000 |