The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Modification To Wilson-cook Lung Biopsy Needle.
| Device ID | K984157 |
| 510k Number | K984157 |
| Device Name: | MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
| Contact | Paula Joyce |
| Correspondent | Paula Joyce WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-19 |
| Decision Date | 1998-12-08 |
| Summary: | summary |