The following data is part of a premarket notification filed by Vision Systems Group, A Division Of Viking Systems with the FDA for 3dhjd Camera System Model.
| Device ID | K101810 |
| 510k Number | K101810 |
| Device Name: | 3DHJD CAMERA SYSTEM MODEL |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS 134 FLANDERS RD. Westborough, MA 01581 |
| Contact | Christine E Nichols Rac |
| Correspondent | Christine E Nichols Rac VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS 134 FLANDERS RD. Westborough, MA 01581 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-29 |
| Decision Date | 2010-08-30 |
| Summary: | summary |