The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for 18 Gauge Tru-cut Biopsy Needle.
| Device ID | K960509 |
| 510k Number | K960509 |
| Device Name: | 18 GAUGE TRU-CUT BIOPSY NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | BAXTER HEALTHCARE CORP. 1500 WAUKEGAN RD. BLDG. K Mcgaw Park, IL 60085 |
| Contact | Sharon Richter |
| Correspondent | Sharon Richter BAXTER HEALTHCARE CORP. 1500 WAUKEGAN RD. BLDG. K 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 | 1996-02-05 |
| Decision Date | 1996-04-04 |
| Summary: | summary |