The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Electro-gyne Electrosurgical Generator.
Device ID | K871960 |
510k Number | K871960 |
Device Name: | ELECTRO-GYNE ELECTROSURGICAL GENERATOR |
Classification | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
Applicant | CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
Contact | John E Mordock |
Correspondent | John E Mordock CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
Product Code | KNF |
CFR Regulation Number | 884.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-20 |
Decision Date | 1987-07-10 |