The following data is part of a premarket notification filed by Symmetry Medical with the FDA for 14.5-16.0 French Cuffed Catheter Removal Device, Symmetry Surgical Singel Use.
| Device ID | K122263 |
| 510k Number | K122263 |
| Device Name: | 14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE |
| Classification | Tunneled Catheter Remover |
| Applicant | SYMMETRY MEDICAL 3034 OWEN DRIVE Antioch, TN 37013 |
| Contact | Hannah Foley |
| Correspondent | Hannah Foley SYMMETRY MEDICAL 3034 OWEN DRIVE Antioch, TN 37013 |
| Product Code | ODY |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-27 |
| Decision Date | 2012-09-28 |
| Summary: | summary |