The following data is part of a premarket notification filed by Stephens Mfg. Co. with the FDA for Guaranty Hair Removal System.
| Device ID | K905125 |
| 510k Number | K905125 |
| Device Name: | GUARANTY HAIR REMOVAL SYSTEM |
| Classification | Epilator, High Frequency, Tweezer-type |
| Applicant | STEPHENS MFG. CO. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan STEPHENS MFG. CO. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Product Code | KCX |
| CFR Regulation Number | 878.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-14 |
| Decision Date | 1991-08-05 |