The following data is part of a premarket notification filed by Medtronic Xomed with the FDA for Trebay Microdebrider Or Xps Straight Shot.
| Device ID | K963246 |
| 510k Number | K963246 |
| Device Name: | TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | MEDTRONIC XOMED 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | David Timlin |
| Correspondent | David Timlin MEDTRONIC XOMED 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-19 |
| Decision Date | 1996-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00681490048941 | K963246 | 000 |
| 00681490048880 | K963246 | 000 |