The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Bariatric Laparoscope, Model 367.
| Device ID | K993045 |
| 510k Number | K993045 |
| Device Name: | BARIATRIC LAPAROSCOPE, MODEL 367 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Contact | Robert H Dahla |
| Correspondent | Robert H Dahla Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-10 |
| Decision Date | 1999-10-27 |
| Summary: | summary |