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 |