The following data is part of a premarket notification filed by Clareblend, Inc. with the FDA for Electronic Epilator.
Device ID | K880553 |
510k Number | K880553 |
Device Name: | ELECTRONIC EPILATOR |
Classification | Epilator, High Frequency, Needle-type |
Applicant | CLAREBLEND, INC. 13026 SAN FERNANDO RD. Sylmar, CA 91342 |
Contact | Margaret M Smith |
Correspondent | Margaret M Smith CLAREBLEND, INC. 13026 SAN FERNANDO RD. Sylmar, CA 91342 |
Product Code | KCW |
CFR Regulation Number | 878.5350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-09 |
Decision Date | 1988-02-29 |