The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Ethicon Endo-surgeryoptical Dilator.
| Device ID | K093236 |
| 510k Number | K093236 |
| Device Name: | ETHICON ENDO-SURGERYOPTICAL DILATOR |
| Classification | Dilator, Esophageal |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Renee Rowe |
| Correspondent | Renee Rowe ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | KNQ |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-15 |
| Decision Date | 2009-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705036003919 | K093236 | 000 |
| 30705036003902 | K093236 | 000 |
| 30705036003896 | K093236 | 000 |