The following data is part of a premarket notification filed by Bioengineering Consultants Ltd. with the FDA for K-c Hemostatic Biopsy System.
| Device ID | K050135 |
| 510k Number | K050135 |
| Device Name: | K-C HEMOSTATIC BIOPSY SYSTEM |
| Classification | Biopsy Needle |
| Applicant | BIOENGINEERING CONSULTANTS LTD. 801 WEST MAIN STREET Charlottesville, VA 22903 |
| Contact | William R Krause |
| Correspondent | William R Krause BIOENGINEERING CONSULTANTS LTD. 801 WEST MAIN STREET Charlottesville, VA 22903 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-21 |
| Decision Date | 2005-07-13 |
| Summary: | summary |