The following data is part of a premarket notification filed by Global Tv Concepts, Ltd. with the FDA for Sonique Hair Remover.
| Device ID | K973174 |
| 510k Number | K973174 |
| Device Name: | SONIQUE 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 |