The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Bovie Button Remote Hand Switch.
| Device ID | K060117 |
| 510k Number | K060117 |
| Device Name: | BOVIE BUTTON REMOTE HAND SWITCH |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 -2902 |
| Contact | Richard A Kozloff |
| Correspondent | Neil E Devine INTERTEK TESTING SERVICES 70 CODMAN HILL RD. Boxborough, MA 01719 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-01-17 |
| Decision Date | 2006-02-22 |
| Summary: | summary |