The following data is part of a premarket notification filed by Foreseeson Custom Displays, Inc. with the FDA for Wis1000.
| Device ID | K112621 |
| 510k Number | K112621 |
| Device Name: | WIS1000 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | FORESEESON CUSTOM DISPLAYS, INC. 2210 E Winston Road Anaheim, CA 92806 |
| Contact | Daniel Tomlinson |
| Correspondent | Daniel Tomlinson FORESEESON CUSTOM DISPLAYS, INC. 2210 E Winston Road Anaheim, CA 92806 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-08 |
| Decision Date | 2012-05-30 |
| Summary: | summary |