The following data is part of a premarket notification filed by R. A. Fischer Co. Corp. with the FDA for Compu-blend Epilator.
Device ID | K954031 |
510k Number | K954031 |
Device Name: | COMPU-BLEND EPILATOR |
Classification | Epilator, High Frequency, Needle-type |
Applicant | R. A. FISCHER CO. CORP. 517 COMMERCIAL ST. Glendale, CA 91203 |
Contact | Mark Van Orden |
Correspondent | Mark Van Orden R. A. FISCHER CO. CORP. 517 COMMERCIAL ST. Glendale, CA 91203 |
Product Code | KCW |
CFR Regulation Number | 878.5350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-28 |
Decision Date | 1996-01-05 |