The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Optical Dvs (dual Vector Shearing) Esophageal Dilator.
| Device ID | K031147 |
| 510k Number | K031147 |
| Device Name: | OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR |
| Classification | Dilator, Esophageal |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Kimberly Shoemaker |
| Correspondent | Kimberly Shoemaker ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | KNQ |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-10 |
| Decision Date | 2004-01-12 |
| Summary: | summary |