The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Proximate And Endopath Linear Cutters And Staplers.
Device ID | K020779 |
510k Number | K020779 |
Device Name: | PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS |
Classification | Staple, Implantable |
Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
Contact | Doug Kentz |
Correspondent | Doug Kentz ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
Product Code | GDW |
CFR Regulation Number | 878.4750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-03-11 |
Decision Date | 2002-06-05 |
Summary: | summary |