The following data is part of a premarket notification filed by Bovie Medical with the FDA for Laparoscopic Resection Device, Model Sr326l.
| Device ID | K091440 |
| 510k Number | K091440 |
| Device Name: | LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BOVIE MEDICAL 5115 ULMERTON ROAD Clearwater, FL 33760 -4004 |
| Contact | Richard Kozloff |
| Correspondent | Richard Kozloff BOVIE MEDICAL 5115 ULMERTON ROAD Clearwater, FL 33760 -4004 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-15 |
| Decision Date | 2009-10-09 |
| Summary: | summary |