The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Sdc3 Hd Information Management System.
| Device ID | K121893 |
| 510k Number | K121893 |
| Device Name: | STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
| Contact | Lifei Liu |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-06-29 |
| Decision Date | 2012-09-05 |
| Summary: | summary |