The following data is part of a premarket notification filed by Precision Electrolysis Needles, Inc. with the FDA for Epilation Needle.
| Device ID | K894771 |
| 510k Number | K894771 |
| Device Name: | EPILATION NEEDLE |
| Classification | Epilator, High Frequency, Needle-type |
| Applicant | PRECISION ELECTROLYSIS NEEDLES, INC. 49 ARNOLD ST. Riverside, RI 02915 |
| Contact | Cary, Iii |
| Correspondent | Cary, Iii PRECISION ELECTROLYSIS NEEDLES, INC. 49 ARNOLD ST. Riverside, RI 02915 |
| Product Code | KCW |
| CFR Regulation Number | 878.5350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-26 |
| Decision Date | 1989-08-21 |