The following data is part of a premarket notification filed by Symmetry Surgical with the FDA for Bookwalter Gordon Adjustable Compression Element.
| Device ID | K143078 |
| 510k Number | K143078 |
| Device Name: | Bookwalter Gordon Adjustable Compression Element |
| Classification | Clamp, Vascular |
| Applicant | SYMMETRY SURGICAL 3034 OWEN DRIVE Antioch, TN 37013 |
| Contact | Victoria Rogers |
| Correspondent | David C Furr FDC Services 8708 Capehart Cove Austin, TX 78733 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-27 |
| Decision Date | 2015-05-14 |
| Summary: | summary |