The following data is part of a premarket notification filed by Vidacare Corporation with the FDA for Oncontrol Bone Marrow Biopsy System.
| Device ID | K072045 |
| 510k Number | K072045 |
| Device Name: | ONCONTROL BONE MARROW BIOPSY SYSTEM |
| Classification | Instrument, Biopsy |
| Applicant | VIDACARE CORPORATION 3722 AVE. SAUSALITO Irvin, CA 92606 |
| Contact | Grace Holland |
| Correspondent | Grace Holland VIDACARE CORPORATION 3722 AVE. SAUSALITO Irvin, 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 | 2007-07-25 |
| Decision Date | 2007-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40816000012473 | K072045 | 000 |