The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Infravision Esophageal Kit.
| Device ID | K983220 |
| 510k Number | K983220 |
| Device Name: | STRYKER INFRAVISION ESOPHAGEAL KIT |
| Classification | Bougie, Esophageal, And Gastrointestinal, Gastro-urology |
| Applicant | Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Contact | Sean Cahill |
| Correspondent | Sean Cahill Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Product Code | FAT |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-14 |
| Decision Date | 1999-06-04 |
| Summary: | summary |