The following data is part of a premarket notification filed by Maxxim Medical with the FDA for Bovie Model X15.
| Device ID | K972161 |
| 510k Number | K972161 |
| Device Name: | BOVIE MODEL X15 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MAXXIM MEDICAL 1070 THORNWOOD LN. Dacula, GA 30211 -3007 |
| Contact | Michael A Clark |
| Correspondent | Michael A Clark MAXXIM MEDICAL 1070 THORNWOOD LN. Dacula, GA 30211 -3007 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-09 |
| Decision Date | 1997-06-18 |