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.
| Device ID | K990864 |
| 510k Number | K990864 |
| Device Name: | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228 |
| Classification | Ligator, Esophageal |
| Applicant | BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537 |
| Contact | Abby Lipman |
| Correspondent | Abby Lipman BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537 |
| Product Code | MND |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-16 |
| Decision Date | 1999-06-11 |
| Summary: | summary |