The following data is part of a premarket notification filed by M.s.t Medical Surgery Technologies Ltd with the FDA for Autolap System.
| Device ID | K152848 |
| 510k Number | K152848 |
| Device Name: | AUTOLAP SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | M.S.T Medical Surgery Technologies LTD Kochav Yokneam Building, Floor 5, POB 685 Yokneam Llit, IL 2069200 |
| Contact | Tami Harel |
| Correspondent | John J Smith HOGAN LOVELLS US LLP 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-29 |
| Decision Date | 2015-11-17 |
| Summary: | summary |