The following data is part of a premarket notification filed by Vitalitec Medizintechnik Gmbh with the FDA for Kerrison Rongeurs.
| Device ID | K152734 |
| 510k Number | K152734 |
| Device Name: | Kerrison Rongeurs |
| Classification | Rongeur, Manual |
| Applicant | VITALITEC MEDIZINTECHNIK GMBH STEIGAECKER 20 Balgheim (baden-wurttem Berg), DE 78582 |
| Contact | Lynette Howard |
| Correspondent | Lynette Howard LYLE HOWARD CORPORATION 106 EAST 5TH AVENUE Mount Dora, FL 32757 |
| Product Code | HAE |
| CFR Regulation Number | 882.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-22 |
| Decision Date | 2016-06-18 |
| Summary: | summary |