The following data is part of a premarket notification filed by Wilson-cook Medical Inc. with the FDA for Cook Gi Endoscopic Injection Gel Kit, Gel-s, Gel-n, Gel-h, Gel-k.
| Device ID | K111495 |
| 510k Number | K111495 |
| Device Name: | COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| 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 | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-31 |
| Decision Date | 2011-07-19 |
| Summary: | summary |