The following data is part of a premarket notification filed by Santa Barbara Imaging Systems with the FDA for 8x-10-xxxx Camera System.
| Device ID | K152513 |
| 510k Number | K152513 |
| Device Name: | 8X-10-XXXX Camera System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Santa Barbara Imaging Systems 340 Storke Road, Suite 101 Goleta, CA 93117 |
| Contact | James Candy |
| Correspondent | James Candy Santa Barbara Imaging Systems 340 Storke Road, Suite 101 Goleta, CA 93117 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-02 |
| Decision Date | 2015-12-15 |
| Summary: | summary |