The following data is part of a premarket notification filed by Regulatory Specialists, Inc. with the FDA for The Oncontrol Bone Access System By Vidacare.
| Device ID | K112468 |
| 510k Number | K112468 |
| Device Name: | THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE |
| Classification | Instrument, Biopsy |
| Applicant | REGULATORY SPECIALISTS, INC. 3722 AVE SAUSALITO Irvine, CA 92606 |
| Contact | Grace Holland |
| Correspondent | Grace Holland REGULATORY SPECIALISTS, INC. 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 | 2011-08-26 |
| Decision Date | 2011-10-20 |
| Summary: | summary |