The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Contour Curved Cutter Stapler And Reloads, Models: Cs40b, Cs40g, Cr40b, Cr40g.
| Device ID | K091322 |
| 510k Number | K091322 |
| Device Name: | CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G |
| Classification | Staple, Implantable |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Asifa Vonhof |
| Correspondent | Asifa Vonhof 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 | 2009-05-05 |
| Decision Date | 2009-06-01 |
| Summary: | summary |