The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Xomed Ball-tip Monopolar Stimulator Probe.
| Device ID | K992869 |
| 510k Number | K992869 |
| Device Name: | XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE |
| Classification | Stimulator, Nerve |
| Applicant | XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Contact | Martin D Sargent |
| Correspondent | Martin D Sargent XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-25 |
| Decision Date | 1999-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169938380 | K992869 | 000 |
| 00643169938373 | K992869 | 000 |
| 00763000036102 | K992869 | 000 |
| 00763000036096 | K992869 | 000 |
| 00763000891879 | K992869 | 000 |
| 00763000891862 | K992869 | 000 |