The following data is part of a premarket notification filed by Wellquest Intl., Inc. with the FDA for Dapelle Hair Remover.
| Device ID | K973773 |
| 510k Number | K973773 |
| Device Name: | DAPELLE HAIR REMOVER |
| Classification | Epilator, High Frequency, Tweezer-type |
| Applicant | WELLQUEST INTL., INC. 230 FIFTH AVE, New York, NY 10001 |
| Contact | Steven Mishan |
| Correspondent | Steven Mishan WELLQUEST INTL., INC. 230 FIFTH AVE, New York, NY 10001 |
| Product Code | KCX |
| CFR Regulation Number | 878.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-02 |
| Decision Date | 1997-12-17 |