The following data is part of a premarket notification filed by General Medical Co. with the FDA for Subderm Tm.
| Device ID | K853635 |
| 510k Number | K853635 |
| Device Name: | SUBDERM TM |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | GENERAL MEDICAL CO. 1575 EYE ST. NW Washington, DC 20005 |
| Contact | Larry R Pilot |
| Correspondent | Larry R Pilot GENERAL MEDICAL CO. 1575 EYE ST. NW Washington, DC 20005 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-30 |
| Decision Date | 1985-12-20 |