The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Hummer Ii Microdebrider System.
| Device ID | K972584 |
| 510k Number | K972584 |
| Device Name: | STRYKER HUMMER II MICRODEBRIDER SYSTEM |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Contact | Carlos Gonzalez |
| Correspondent | Carlos Gonzalez 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 | 1997-07-10 |
| Decision Date | 1997-10-01 |
| Summary: | summary |