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 |