The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Hummer Iv Microdebrider System.
| Device ID | K011381 |
| 510k Number | K011381 |
| Device Name: | HUMMER IV MICRODEBRIDER SYSTEM |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Robin L Rowe |
| Correspondent | Robin L Rowe STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-07 |
| Decision Date | 2001-05-25 |