The following data is part of a premarket notification filed by R. A. Fischer Co. Corp. with the FDA for Md-2 Iontophoresis Unit.
| Device ID | K895365 |
| 510k Number | K895365 |
| Device Name: | MD-2 IONTOPHORESIS UNIT |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | R. A. FISCHER CO. CORP. 517 COMMERCIAL ST. Glendale, CA 91203 |
| Contact | Van Orden |
| Correspondent | Van Orden R. A. FISCHER CO. CORP. 517 COMMERCIAL ST. Glendale, CA 91203 |
| 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 | 1989-08-28 |
| Decision Date | 1990-06-26 |