The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Biopty-cut Biopsy Needle/with Spacer.
| Device ID | K962077 |
| 510k Number | K962077 |
| Device Name: | BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER |
| Classification | Instrument, Biopsy |
| Applicant | C.R. BARD, INC. 129 CONCORD RD., BLDG. #3 Billerica, MA 01821 |
| Contact | Carol Vierling |
| Correspondent | Carol Vierling C.R. BARD, INC. 129 CONCORD RD., BLDG. #3 Billerica, MA 01821 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-28 |
| Decision Date | 1996-07-30 |
| Summary: | summary |