The following data is part of a premarket notification filed by Endoscopic Technologies, Inc. with the FDA for Disposible Electro Coagulation Probe.
Device ID | K924057 |
510k Number | K924057 |
Device Name: | DISPOSIBLE ELECTRO COAGULATION PROBE |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | ENDOSCOPIC TECHNOLOGIES, INC. 2225 SKYLAND COURT Norcross, GA 30071 |
Contact | Freddie P Andrieni |
Correspondent | Freddie P Andrieni ENDOSCOPIC TECHNOLOGIES, INC. 2225 SKYLAND COURT 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 | 1992-08-12 |
Decision Date | 1994-03-11 |