The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. / Cook Endoscopy with the FDA for Disposable Hemostasis Chip.
| Device ID | K121505 |
| 510k Number | K121505 |
| Device Name: | DISPOSABLE HEMOSTASIS CHIP |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY 4900 BETHANIA STATION ROAD Winston-salem, NC 27105 |
| Contact | Scottie Fariole |
| Correspondent | Scottie Fariole WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY 4900 BETHANIA STATION ROAD Winston-salem, NC 27105 |
| Product Code | PKL |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-21 |
| Decision Date | 2012-08-31 |
| Summary: | summary |