The following data is part of a premarket notification filed by Global Tronics Intl., Inc. with the FDA for Hair Tronics Model Ht8000.
| Device ID | K915845 |
| 510k Number | K915845 |
| Device Name: | HAIR TRONICS MODEL HT8000 |
| Classification | Epilator, High Frequency, Tweezer-type |
| Applicant | GLOBAL TRONICS INTL., INC. 2626 LAVERY COURT, SUITE 301 Newbury Park, CA 91320 |
| Contact | Mantell, Jr. |
| Correspondent | Mantell, Jr. GLOBAL TRONICS INTL., INC. 2626 LAVERY COURT, SUITE 301 Newbury Park, CA 91320 |
| Product Code | KCX |
| CFR Regulation Number | 878.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-26 |
| Decision Date | 1992-07-29 |