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 |