The following data is part of a premarket notification filed by Burke Neutech, Inc. with the FDA for Epilator.
| Device ID | K952117 |
| 510k Number | K952117 |
| Device Name: | EPILATOR |
| Classification | Epilator, High Frequency, Tweezer-type |
| Applicant | BURKE NEUTECH, INC. 1765 COMMERCE AVE. NORTH St. Petersburg, FL 33716 |
| Contact | Robert E Burke |
| Correspondent | Robert E Burke BURKE NEUTECH, INC. 1765 COMMERCE AVE. NORTH St. Petersburg, FL 33716 |
| Product Code | KCX |
| CFR Regulation Number | 878.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-05 |
| Decision Date | 1995-10-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EPILATOR 71185709 0180521 Dead/Expired |
JEAN JOCDEAU, INC. 1923-09-12 |