The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Speedband Superview Multiple Band Ligator.
| Device ID | K981669 |
| 510k Number | K981669 |
| Device Name: | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR |
| Classification | Ligator, Hemorrhoidal |
| Applicant | BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 |
| Contact | Lisa M Quaglia |
| Correspondent | Lisa M Quaglia BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 |
| Product Code | FHN |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-12 |
| Decision Date | 1998-06-04 |
| Summary: | summary |