The following data is part of a premarket notification filed by Medsys, S.a. with the FDA for Lapman Laparoscope Manipulator And Accessories, Model 900-200 Series.
| Device ID | K062968 |
| 510k Number | K062968 |
| Device Name: | LAPMAN LAPAROSCOPE MANIPULATOR AND ACCESSORIES, MODEL 900-200 SERIES |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MEDSYS, S.A. 13723 DANA LN. EAST Puyallup, WA 98373 |
| Contact | Jeff Morgan |
| Correspondent | Jeff Morgan MEDSYS, S.A. 13723 DANA LN. EAST Puyallup, WA 98373 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-29 |
| Decision Date | 2007-01-03 |
| Summary: | summary |