The following data is part of a premarket notification filed by Symmetry Surgical Inc. with the FDA for Symmetry Sharp Kerrison Rongeur.
| Device ID | K161744 |
| 510k Number | K161744 |
| Device Name: | Symmetry Sharp Kerrison Rongeur |
| Classification | Rongeur, Manual |
| Applicant | Symmetry Surgical Inc. 3034 Owen Drive Antioch, TN 37013 |
| Contact | Lora Tjomstol |
| Correspondent | Michele Lucey Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury, NH 03255 |
| Product Code | HAE |
| CFR Regulation Number | 882.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-24 |
| Decision Date | 2016-09-07 |
| Summary: | summary |