The following data is part of a premarket notification filed by Symmetry Surgical with the FDA for Symmetry Kerrison Disposable Tip Rongeurs.
| Device ID | K130541 |
| 510k Number | K130541 |
| Device Name: | SYMMETRY KERRISON DISPOSABLE TIP RONGEURS |
| Classification | Rongeur, Manual |
| Applicant | SYMMETRY SURGICAL 1927 N. ARTHUR DR. Columbia City, IN 46725 |
| Contact | Dalene Binkley |
| Correspondent | Dalene Binkley SYMMETRY SURGICAL 1927 N. ARTHUR DR. Columbia City, IN 46725 |
| Product Code | HAE |
| CFR Regulation Number | 882.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-01 |
| Decision Date | 2013-08-05 |
| Summary: | summary |