The following data is part of a premarket notification filed by Santa Barbara Medco, Inc. with the FDA for Santa Barbara Medco-lantophoretic Applic.
| Device ID | K842483 |
| 510k Number | K842483 |
| Device Name: | SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | SANTA BARBARA MEDCO, INC. P.O. BOX 6843 Santa Barbara, CA 93111 |
| Contact | David G Esslinger |
| Correspondent | David G Esslinger SANTA BARBARA MEDCO, INC. P.O. BOX 6843 Santa Barbara, CA 93111 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-25 |
| Decision Date | 1984-08-31 |