The following data is part of a premarket notification filed by A.r. Hinkel Co., Inc. with the FDA for Electro-blend Epilator, Model Uc-3.
Device ID | K904015 |
510k Number | K904015 |
Device Name: | ELECTRO-BLEND EPILATOR, MODEL UC-3 |
Classification | Epilator, High Frequency, Needle-type |
Applicant | A.R. HINKEL CO., INC. 18121-C PARTHENIA ST. Northridge, CA 91325 |
Contact | William A Schuler |
Correspondent | William A Schuler A.R. HINKEL CO., INC. 18121-C PARTHENIA ST. Northridge, CA 91325 |
Product Code | KCW |
CFR Regulation Number | 878.5350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-31 |
Decision Date | 1990-10-04 |