The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endopath Ez-rf Linear Cutter And Coagulation.
Device ID | K961264 |
510k Number | K961264 |
Device Name: | ENDOPATH EZ-RF LINEAR CUTTER AND COAGULATION |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
Contact | Lorri J Charvez |
Correspondent | Lorri J Charvez ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-04-02 |
Decision Date | 1996-07-19 |
Summary: | summary |