The following data is part of a premarket notification filed by R. A. Fischer Co. Corp. with the FDA for Electronic Epilator Ts-1.
Device ID | K843063 |
510k Number | K843063 |
Device Name: | ELECTRONIC EPILATOR TS-1 |
Classification | Epilator, High Frequency, Needle-type |
Applicant | R. A. FISCHER CO. CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KCW |
CFR Regulation Number | 878.5350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-06 |
Decision Date | 1984-09-26 |