The following data is part of a premarket notification filed by R. A. Fischer Co. Corp. with the FDA for Epilator, Model Cp-16.
Device ID | K801351 |
510k Number | K801351 |
Device Name: | EPILATOR, MODEL CP-16 |
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 | 1980-06-09 |
Decision Date | 1980-07-28 |