The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Skinny,franseen,wescott Needles.
| Device ID | K962907 |
| 510k Number | K962907 |
| Device Name: | SKINNY,FRANSEEN,WESCOTT NEEDLES |
| Classification | Instrument, Biopsy |
| Applicant | BAXTER HEALTHCARE CORP. 1500 WAUKEGAN RD. BLDG. K Mcgaw Park, IL 60085 |
| Contact | Sharon Robbins |
| Correspondent | Sharon Robbins 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 | 1996-07-25 |
| Decision Date | 1996-10-23 |
| Summary: | summary |