The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Hummer Trak System.
| Device ID | K990038 |
| 510k Number | K990038 |
| Device Name: | HUMMER TRAK SYSTEM |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Contact | David Himes |
| Correspondent | David Himes Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-06 |
| Decision Date | 1999-02-19 |
| Summary: | summary |