The following data is part of a premarket notification filed by Bard Gynecology And Radiology with the FDA for Coaxial Biopsy Needle.
| Device ID | K936194 |
| 510k Number | K936194 |
| Device Name: | COAXIAL BIOPSY NEEDLE |
| Classification | Biopsy Needle |
| Applicant | BARD GYNECOLOGY AND RADIOLOGY 10115 HIGHWAY 142 Covington, GA 30209 |
| Contact | Teresa Dorriety |
| Correspondent | Teresa Dorriety BARD GYNECOLOGY AND RADIOLOGY 10115 HIGHWAY 142 Covington, GA 30209 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-29 |
| Decision Date | 1994-03-22 |