The following data is part of a premarket notification filed by Martin Electric Co. with the FDA for Debutron.
| Device ID | K782119 |
| 510k Number | K782119 |
| Device Name: | DEBUTRON |
| Classification | Epilator, High Frequency, Tweezer-type |
| Applicant | MARTIN ELECTRIC CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KCX |
| CFR Regulation Number | 878.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-12-27 |
| Decision Date | 1979-02-26 |