The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Howell Biliary Aspiration Needle.
| Device ID | K153763 |
| 510k Number | K153763 |
| Device Name: | Howell Biliary Aspiration Needle |
| Classification | Instrument, Biopsy, Suction |
| Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION ROAD Winston Salem, NC 27105 |
| Contact | Jennifer Mcmahan |
| Correspondent | Ashley Howard WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION ROAD Winston Salem, NC 27105 |
| Product Code | FCK |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-30 |
| Decision Date | 2017-04-06 |
| Summary: | summary |