The following data is part of a premarket notification filed by Scivita Medical Technology Co., Ltd with the FDA for 3d Visualization System.
| Device ID | K183675 |
| 510k Number | K183675 |
| Device Name: | 3D Visualization System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Scivita Medical Technology Co., Ltd No.8, Zhong Tian Xiang, Suzhou Industrial Park Suzhou, CN 215000 |
| Contact | Ruqin Wu |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai, CN 200120 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-28 |
| Decision Date | 2019-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971381250053 | K183675 | 000 |
| 06971381250046 | K183675 | 000 |
| 06971381250039 | K183675 | 000 |
| 06971381250022 | K183675 | 000 |
| 06971381250015 | K183675 | 000 |