The following data is part of a premarket notification filed by Resect Medical, Inc. with the FDA for Resect Medical Inline Bi-polar Rf Linear Coagulation Device.
| Device ID | K040763 |
| 510k Number | K040763 |
| Device Name: | RESECT MEDICAL INLINE BI-POLAR RF LINEAR COAGULATION DEVICE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RESECT MEDICAL, INC. 40874 CALIDO PLACE Fremont, CA 94539 |
| Contact | Nancy Lince |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-03-25 |
| Decision Date | 2004-04-08 |
| Summary: | summary |