The following data is part of a premarket notification filed by Sopro with the FDA for Sopro 184 Camera.
| Device ID | K082796 |
| 510k Number | K082796 |
| Device Name: | SOPRO 184 CAMERA |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SOPRO 124 GAITHER DRIVE SUITE 140 Mt. Laurel, NJ 08054 |
| Contact | Rick Rosati |
| Correspondent | Rick Rosati SOPRO 124 GAITHER DRIVE SUITE 140 Mt. Laurel, NJ 08054 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-23 |
| Decision Date | 2009-04-01 |
| Summary: | summary |