The following data is part of a premarket notification filed by Medical Adhesiveonline, Llc. with the FDA for Medical Adhesiveonline, Llc. Iontophoresis Drug Delivery Electrodes, Models 23001, 23002, 23003, 23004, And 24001.
| Device ID | K041101 |
| 510k Number | K041101 |
| Device Name: | MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001 |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | MEDICAL ADHESIVEONLINE, LLC. 10809 GARDEN MIST #2045 Las Vegas, NV 89135 |
| Contact | Adam Shaw |
| Correspondent | Adam Shaw MEDICAL ADHESIVEONLINE, LLC. 10809 GARDEN MIST #2045 Las Vegas, NV 89135 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2004-04-26 |
| Decision Date | 2004-07-07 |
| Summary: | summary |