The following data is part of a premarket notification filed by R. A. Fischer Co. Corp. with the FDA for Model Se-5 Epilator.
| Device ID | K893389 |
| 510k Number | K893389 |
| Device Name: | MODEL SE-5 EPILATOR |
| Classification | Epilator, High Frequency, Needle-type |
| Applicant | R. A. FISCHER CO. CORP. 517 COMMERCIAL ST. Glendale, CA 91203 |
| Contact | Van Orden |
| Correspondent | 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 | 1989-05-01 |
| Decision Date | 1989-06-05 |