The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Echelon Gray Cartridge, Model Erc45m.
| Device ID | K080839 |
| 510k Number | K080839 |
| Device Name: | ECHELON GRAY CARTRIDGE, MODEL ERC45M |
| Classification | Staple, Implantable |
| Applicant | ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Contact | Ruth Ann Wood |
| Correspondent | Ruth Ann Wood ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-25 |
| Decision Date | 2008-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705036013796 | K080839 | 000 |
| 30705036001755 | K080839 | 000 |