The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Speedband Superview Multiple Band Ligator, Models 4225, 4228; Injection Speedband Superview Multiple Band Ligator, Model.
| Device ID | K000397 |
| 510k Number | K000397 |
| Device Name: | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL |
| Classification | Ligator, Hemorrhoidal |
| Applicant | BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PLACE Natick, MA 01760 -1537 |
| Contact | Abby Lipman |
| Correspondent | Abby Lipman BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PLACE Natick, MA 01760 -1537 |
| Product Code | FHN |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-07 |
| Decision Date | 2000-03-07 |