The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Essential Shaver System.
| Device ID | K974232 |
| 510k Number | K974232 |
| Device Name: | ESSENTIAL SHAVER SYSTEM |
| Classification | Bur, Ear, Nose And Throat |
| Applicant | GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Deborah A Arthur |
| Correspondent | Deborah A Arthur GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Product Code | EQJ |
| CFR Regulation Number | 874.4140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-12 |
| Decision Date | 1998-01-12 |
| Summary: | summary |