510(k) K874891
K874891 is an FDA 510(k) premarket notification submitted by Skin Deep, Inc. for the device "FLEXIE THE COPPER SHANK NEEDLE". The FDA issued a decision of Substantially Equivalent on Jan 7, 1988. The device falls under product code KCW (Epilator, High Frequency, Needle-Type), a Class I device regulated under 21 CFR 878.5350. Skin Deep, Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 7, 1988
- Date Received
- Dec 1, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Epilator, High Frequency, Needle-Type
- Device Class
- Class I
- Regulation Number
- 878.5350
- Review Panel
- SU
- Submission Type
- 510(k) Exempt