The following data is part of a premarket notification filed by Cook Ireland Ltd with the FDA for Shortshot Saeed Hemorrhoidal Multi-band Ligator With Triview Anoscope.
| Device ID | K060623 |
| 510k Number | K060623 |
| Device Name: | SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE |
| Classification | Anoscope And Accessories |
| Applicant | COOK IRELAND LTD O'HOLLORAN ROAD NATIONAL TECHNOLOGICAL PARK Limerick, IE |
| Contact | Emmett Devereux |
| Correspondent | Emmett Devereux COOK IRELAND LTD O'HOLLORAN ROAD NATIONAL TECHNOLOGICAL PARK Limerick, IE |
| Product Code | FER |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-08 |
| Decision Date | 2006-09-06 |
| Summary: | summary |