The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Stimulus/dissection Instruments, Ball-tip Probes.
| Device ID | K031003 |
| 510k Number | K031003 |
| Device Name: | STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES |
| Classification | Stimulator, Nerve |
| Applicant | MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | Martin D Sargent |
| Correspondent | Martin D Sargent MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-31 |
| Decision Date | 2003-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994131645 | K031003 | 000 |
| 00885074101347 | K031003 | 000 |
| 00885074101361 | K031003 | 000 |
| 00885074286341 | K031003 | 000 |
| 00763000036324 | K031003 | 000 |
| 00763000036331 | K031003 | 000 |
| 00763000036690 | K031003 | 000 |
| 00721902572654 | K031003 | 000 |
| 00721902572715 | K031003 | 000 |
| 00721902600951 | K031003 | 000 |
| 00721902670756 | K031003 | 000 |
| 00721902670763 | K031003 | 000 |
| 20721902572702 | K031003 | 000 |