The following data is part of a premarket notification filed by R. A. Fischer Co. Corp. with the FDA for Md-1a Galvanic Unit.
| Device ID | K964208 |
| 510k Number | K964208 |
| Device Name: | MD-1A GALVANIC UNIT |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | R. A. FISCHER CO. CORP. 517 COMMERCIAL ST. Glendale, CA 91203 |
| Contact | Mark Van Orden |
| Correspondent | Mark Van Orden R. A. FISCHER CO. CORP. 517 COMMERCIAL ST. Glendale, CA 91203 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-04 |
| Decision Date | 1997-04-30 |