The following data is part of a premarket notification filed by Galvanic Medical Instruments, Inc. with the FDA for Guibor Microelectrolysis Unit 18.
| Device ID | K851318 |
| 510k Number | K851318 |
| Device Name: | GUIBOR MICROELECTROLYSIS UNIT 18 |
| Classification | Epilator, High Frequency, Needle-type |
| Applicant | GALVANIC MEDICAL INSTRUMENTS, INC. P.O. BOX 1042 Paramus, NJ 07652 |
| Contact | David |
| Correspondent | David GALVANIC MEDICAL INSTRUMENTS, INC. P.O. BOX 1042 Paramus, NJ 07652 |
| Product Code | KCW |
| CFR Regulation Number | 878.5350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-02 |
| Decision Date | 1985-08-20 |