The following data is part of a premarket notification filed by Vidacare Corporation with the FDA for The Oncontrol Bone Access And Bone Biopsy System By Vidacare.
| Device ID | K113872 |
| 510k Number | K113872 |
| Device Name: | THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE |
| Classification | Instrument, Biopsy |
| Applicant | VIDACARE CORPORATION 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Grace Holland |
| Correspondent | Grace Holland VIDACARE CORPORATION 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-30 |
| Decision Date | 2012-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30816000012421 | K113872 | 000 |
| 30816000012407 | K113872 | 000 |
| 30816000012384 | K113872 | 000 |
| 30816000012360 | K113872 | 000 |
| 30816000012346 | K113872 | 000 |
| 30816000012322 | K113872 | 000 |
| 30816000012414 | K113872 | 000 |
| 30816000012339 | K113872 | 000 |