The following data is part of a premarket notification filed by Cardinal Health, Inc. with the FDA for Coaxial Bone And Vertebral Body Biopsy Needle Model# Jbc1213, Jbc1208.
| Device ID | K070091 |
| 510k Number | K070091 |
| Device Name: | COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208 |
| Classification | Instrument, Biopsy |
| Applicant | CARDINAL HEALTH, INC. 1430 WAUKEGAN ROAD- MPKB-3B Mcgaw Park, IL 60085 |
| Contact | Sharon Nichols |
| Correspondent | Sharon Nichols CARDINAL HEALTH, INC. 1430 WAUKEGAN ROAD- MPKB-3B Mcgaw Park, IL 60085 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-10 |
| Decision Date | 2007-04-18 |
| Summary: | summary |