The following data is part of a premarket notification filed by Ethicon Endo-sugery, Llc with the FDA for Echelon Zebra Cartridges, Models, Z45wb, Z45bg, Z45gp, Z60wb, Z60bg, Zp60gp.
| Device ID | K080972 |
| 510k Number | K080972 |
| Device Name: | ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP |
| Classification | Staple, Implantable |
| Applicant | ETHICON ENDO-SUGERY, LLC 4545 CREEK RD. Cincinnati, OH 45242 |
| Contact | Ruth A Wood |
| Correspondent | Ruth A Wood ETHICON ENDO-SUGERY, LLC 4545 CREEK RD. 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 | 2008-04-04 |
| Decision Date | 2008-07-03 |
| Summary: | summary |