The following data is part of a premarket notification filed by Alexander Thomas, Inc. with the FDA for Microprocessor Contr/multi-needle, Galvan Epilator.
| Device ID | K864289 |
| 510k Number | K864289 |
| Device Name: | MICROPROCESSOR CONTR/MULTI-NEEDLE, GALVAN EPILATOR |
| Classification | Epilator, High Frequency, Needle-type |
| Applicant | ALEXANDER THOMAS, INC. 120-2A PACIFIC AVE. Collingswood, NJ 08108 |
| Contact | Thomas Guerrieri |
| Correspondent | Thomas Guerrieri ALEXANDER THOMAS, INC. 120-2A PACIFIC AVE. Collingswood, NJ 08108 |
| Product Code | KCW |
| CFR Regulation Number | 878.5350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-31 |
| Decision Date | 1986-12-01 |