The following data is part of a premarket notification filed by Empi with the FDA for Hybresis Iontophoresis Drug Delivery System.
| Device ID | K072946 |
| 510k Number | K072946 |
| Device Name: | HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | EMPI 599 CARDIGAN RD. St. Paul, MN 55126 |
| Contact | Sandra Walrod |
| Correspondent | Sandra Walrod EMPI 599 CARDIGAN RD. St. Paul, MN 55126 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-17 |
| Decision Date | 2007-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190446238225 | K072946 | 000 |
| 00190446238201 | K072946 | 000 |
| 00190446238188 | K072946 | 000 |