The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Speedband Superview Super 7, Injection Speedband Superview Super 7, Models 4205 And 4238.
| Device ID | K020824 |
| 510k Number | K020824 |
| Device Name: | SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238 |
| Classification | Ligator, Hemorrhoidal |
| Applicant | BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PLACE Natick, MA 01760 -1537 |
| Contact | Kathleen Morahan |
| Correspondent | Kathleen Morahan 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 | 2002-03-14 |
| Decision Date | 2002-04-12 |
| Summary: | summary |