The following data is part of a premarket notification filed by Global Tv Concepts, Ltd. with the FDA for Feminique Sonic Hair Remover.
Device ID | K973179 |
510k Number | K973179 |
Device Name: | FEMINIQUE SONIC HAIR REMOVER |
Classification | Epilator, High Frequency, Tweezer-type |
Applicant | GLOBAL TV CONCEPTS, LTD. 700 THIRTEENTH ST., N.W. Washington, DC 20005 |
Contact | Samia N Rodriguez |
Correspondent | Samia N Rodriguez GLOBAL TV CONCEPTS, LTD. 700 THIRTEENTH ST., N.W. Washington, DC 20005 |
Product Code | KCX |
CFR Regulation Number | 878.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-25 |
Decision Date | 1997-10-30 |
Summary: | summary |