The following data is part of a premarket notification filed by Oktas with the FDA for 3d Scope.
| Device ID | K961182 |
| 510k Number | K961182 |
| Device Name: | 3D SCOPE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | OKTAS 134 FLANDERS RD. Westborough, MA 01581 |
| Contact | Debbie Iampietro |
| Correspondent | Debbie Iampietro OKTAS 134 FLANDERS RD. Westborough, MA 01581 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-26 |
| Decision Date | 1996-07-19 |
| Summary: | summary |