The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Hummer Ii Microdebrider System.
| Device ID | K952681 |
| 510k Number | K952681 |
| Device Name: | STRYKER HUMMER II MICRODEBRIDER SYSTEM |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | Stryker Endoscopy 210 BAYPOINTE PKWY. San Jose, CA 95134 |
| Contact | Jeff Kablik |
| Correspondent | Jeff Kablik Stryker Endoscopy 210 BAYPOINTE PKWY. San Jose, CA 95134 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-12 |
| Decision Date | 1995-07-20 |