The following data is part of a premarket notification filed by Vidacare Llc with the FDA for The Oncontrol Bone Marrow Biopsy System By Vidacare.
| Device ID | K142377 |
| 510k Number | K142377 |
| Device Name: | The OnControl Bone Marrow Biopsy System By Vidacare |
| Classification | Instrument, Biopsy |
| Applicant | VIDACARE LLC 4350 LOCKHILL SELMA RD. Shavano Park, TX 78249 |
| Contact | Diana Montez |
| Correspondent | Diana Montez VIDACARE LLC 4350 LOCKHILL SELMA RD. Shavano Park, TX 78249 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-26 |
| Decision Date | 2014-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20816000012288 | K142377 | 000 |
| 20801902217268 | K142377 | 000 |
| 20801902216391 | K142377 | 000 |
| 20801902212928 | K142377 | 000 |
| 20801902216087 | K142377 | 000 |
| 30816000012247 | K142377 | 000 |
| 30816000012292 | K142377 | 000 |
| 30816000012308 | K142377 | 000 |
| 20801902215011 | K142377 | 000 |
| 20801902212423 | K142377 | 000 |
| 20801902203162 | K142377 | 000 |
| 20801902203179 | K142377 | 000 |
| 30816000012490 | K142377 | 000 |
| 40816000012503 | K142377 | 000 |
| 30816000012254 | K142377 | 000 |
| 30816000012230 | K142377 | 000 |
| 30816000012261 | K142377 | 000 |
| 20816000012271 | K142377 | 000 |
| 20801902212904 | K142377 | 000 |