The following data is part of a premarket notification filed by Dura Corp., The with the FDA for Depilatory, Electronic.
Device ID | K772322 |
510k Number | K772322 |
Device Name: | DEPILATORY, ELECTRONIC |
Classification | Epilator, High Frequency, Tweezer-type |
Applicant | DURA CORP., THE 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | KCX |
CFR Regulation Number | 878.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-12-19 |
Decision Date | 1978-01-03 |