The following data is part of a premarket notification filed by Endotec, Inc. with the FDA for Electrosurgical Cutting & Coagulation Device Accessories.
| Device ID | K945254 |
| 510k Number | K945254 |
| Device Name: | ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ENDOTEC, INC. 6550A BEST FRIEND RD. Norcross, GA 30071 |
| Contact | Freddie P Andrieni |
| Correspondent | Freddie P Andrieni ENDOTEC, INC. 6550A BEST FRIEND RD. Norcross, GA 30071 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-28 |
| Decision Date | 1995-06-06 |