The following data is part of a premarket notification filed by Anova Corporation with the FDA for Anova Containment Device.
| Device ID | K063461 |
| 510k Number | K063461 |
| Device Name: | ANOVA CONTAINMENT DEVICE |
| Classification | Mesh, Surgical, Metal |
| Applicant | ANOVA CORPORATION 2001 PENNSYLVANIA AVE., NW Washington, DC 20006 |
| Contact | Campbell Tuskey |
| Correspondent | Campbell Tuskey ANOVA CORPORATION 2001 PENNSYLVANIA AVE., NW Washington, DC 20006 |
| Product Code | EZX |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-15 |
| Decision Date | 2009-08-13 |
| Summary: | summary |