The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Wilson-cook Gi Aspiration Needle.
| Device ID | K934356 |
| 510k Number | K934356 |
| Device Name: | WILSON-COOK GI ASPIRATION NEEDLE |
| Classification | Biopsy Needle |
| Applicant | WILSON-COOK MEDICAL, INC. P.O.BOX 2402 West Lafayette, IN 47906 |
| Contact | Neal E Fearnot |
| Correspondent | Neal E Fearnot WILSON-COOK MEDICAL, INC. P.O.BOX 2402 West Lafayette, IN 47906 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-07 |
| Decision Date | 1994-01-07 |
| Summary: | summary |