The following data is part of a premarket notification filed by Bovie Medical with the FDA for Bovie Ids-400 Electrosurgical Generator.
Device ID | K072041 |
510k Number | K072041 |
Device Name: | BOVIE IDS-400 ELECTROSURGICAL GENERATOR |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | BOVIE MEDICAL 3200 TYRONE BLVD., STE. A St. Petersburg, FL 33710 -2902 |
Contact | Richard A Kozloff |
Correspondent | Richard A Kozloff BOVIE MEDICAL 3200 TYRONE BLVD., STE. A St. Petersburg, FL 33710 -2902 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-07-25 |
Decision Date | 2008-04-10 |
Summary: | summary |