510(k) K915845
K915845 is an FDA 510(k) premarket notification submitted by Global Tronics Intl., Inc. for the device "HAIR TRONICS MODEL HT8000". The FDA issued a decision of Substantially Equivalent on Jul 29, 1992. The device falls under product code KCX (Epilator, High Frequency, Tweezer-Type), a Class I device regulated under 21 CFR 878.5360.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 29, 1992
- Date Received
- Dec 26, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Epilator, High Frequency, Tweezer-Type
- Device Class
- Class I
- Regulation Number
- 878.5360
- Review Panel
- SU
- Submission Type
- 510(k) Exempt