The following data is part of a premarket notification filed by Dectro Intl., Inc. with the FDA for Apilus Electropil.
| Device ID | K943928 |
| 510k Number | K943928 |
| Device Name: | APILUS ELECTROPIL |
| Classification | Epilator, High Frequency, Needle-type |
| Applicant | DECTRO INTL., INC. 2065 BOUL CHAREST O. Sainte-foy (quebec), CA G1n 2g1 |
| Contact | Denis Bourgault |
| Correspondent | Denis Bourgault DECTRO INTL., INC. 2065 BOUL CHAREST O. Sainte-foy (quebec), CA G1n 2g1 |
| Product Code | KCW |
| CFR Regulation Number | 878.5350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-12 |
| Decision Date | 1995-01-12 |