The following data is part of a premarket notification filed by Bovie Medical Corporation with the FDA for Bovie Resistick Ii Coated Electrosurgical Electrodes.
Device ID | K093025 |
510k Number | K093025 |
Device Name: | BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | BOVIE MEDICAL CORPORATION 5115 Ulmerton Road Clearwater, FL 33760 -0000 |
Contact | Richard Kozloff |
Correspondent | Richard Kozloff BOVIE MEDICAL CORPORATION 5115 Ulmerton Road Clearwater, FL 33760 -0000 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-09-29 |
Decision Date | 2009-12-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10607151005822 | K093025 | 000 |
10607151005662 | K093025 | 000 |
10607151005655 | K093025 | 000 |
10607151005648 | K093025 | 000 |
10607151005631 | K093025 | 000 |
20612479210114 | K093025 | 000 |
20612479210107 | K093025 | 000 |
20612479210091 | K093025 | 000 |
20612479210084 | K093025 | 000 |
20612479210077 | K093025 | 000 |
20612479210060 | K093025 | 000 |
10889942241736 | K093025 | 000 |
10889942241729 | K093025 | 000 |
10607151005679 | K093025 | 000 |
10607151005686 | K093025 | 000 |
10607151005693 | K093025 | 000 |
10607151005815 | K093025 | 000 |
10607151005808 | K093025 | 000 |
10607151005792 | K093025 | 000 |
10607151005785 | K093025 | 000 |
10607151005778 | K093025 | 000 |
10607151005761 | K093025 | 000 |
10607151005754 | K093025 | 000 |
10607151005747 | K093025 | 000 |
10607151005730 | K093025 | 000 |
10607151005723 | K093025 | 000 |
10607151005716 | K093025 | 000 |
10607151005709 | K093025 | 000 |
10889942241712 | K093025 | 000 |