The following data is part of a premarket notification filed by Wilson-cook Medical Inc. with the FDA for Echo Tip Ultra Fiducial Needle.
| Device ID | K141356 |
| 510k Number | K141356 |
| Device Name: | ECHO TIP ULTRA FIDUCIAL NEEDLE |
| Classification | Marker, Radiographic, Implantable |
| Applicant | WILSON-COOK MEDICAL INC. 4900 Bethania Station Rd Winston Salem, NC 27105 |
| Contact | Marge Walls-walker |
| Correspondent | Marge Walls-walker WILSON-COOK MEDICAL INC. 4900 Bethania Station Rd Winston Salem, NC 27105 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-23 |
| Decision Date | 2014-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002037939 | K141356 | 000 |