The following data is part of a premarket notification filed by American Hair Removal System Co. with the FDA for Ahrs Epilator 629.
Device ID | K892514 |
510k Number | K892514 |
Device Name: | AHRS EPILATOR 629 |
Classification | Epilator, High Frequency, Tweezer-type |
Applicant | AMERICAN HAIR REMOVAL SYSTEM CO. 160 S. MAY ST. Southern Pines, NC 28387 |
Contact | Lee Cole |
Correspondent | Lee Cole AMERICAN HAIR REMOVAL SYSTEM CO. 160 S. MAY ST. Southern Pines, NC 28387 |
Product Code | KCX |
CFR Regulation Number | 878.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-11 |
Decision Date | 1990-08-14 |