The following data is part of a premarket notification filed by Skin Deep, Inc. with the FDA for Flexie The Copper Shank Needle.
| Device ID | K874891 |
| 510k Number | K874891 |
| Device Name: | FLEXIE THE COPPER SHANK NEEDLE |
| Classification | Epilator, High Frequency, Needle-type |
| Applicant | SKIN DEEP, INC. 1926 COTTMAN AVE. Philadelphia, PA 19111 |
| Contact | Katherine Lasker |
| Correspondent | Katherine Lasker SKIN DEEP, INC. 1926 COTTMAN AVE. Philadelphia, PA 19111 |
| Product Code | KCW |
| CFR Regulation Number | 878.5350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-01 |
| Decision Date | 1988-01-07 |