The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Stimulating Bur Guard.
| Device ID | K063305 |
| 510k Number | K063305 |
| Device Name: | STIMULATING BUR GUARD |
| Classification | Stimulator, Nerve |
| Applicant | MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | Antoine Kouchakjy |
| Correspondent | Antoine Kouchakjy MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-01 |
| Decision Date | 2006-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994315977 | K063305 | 000 |
| 00613994315960 | K063305 | 000 |
| 00763000576776 | K063305 | 000 |
| 00763000576769 | K063305 | 000 |