The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Xomed Ionesthetizer(tm).
| Device ID | K884834 |
| 510k Number | K884834 |
| Device Name: | XOMED IONESTHETIZER(TM) |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Contact | Gordon Peters |
| Correspondent | Gordon Peters XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-18 |
| Decision Date | 1989-02-15 |