The following data is part of a premarket notification filed by Haemoband Surgical Ltd. with the FDA for Haemoband Multi-ligator.
| Device ID | K091519 |
| 510k Number | K091519 |
| Device Name: | HAEMOBAND MULTI-LIGATOR |
| Classification | Ligator, Hemorrhoidal |
| Applicant | HAEMOBAND SURGICAL LTD. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden HAEMOBAND SURGICAL LTD. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | FHN |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-22 |
| Decision Date | 2009-07-28 |
| Summary: | summary |