510(k) K981669
K981669 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR". The FDA issued a decision of Substantially Equivalent on June 4, 1998. The device falls under product code FHN (Ligator, Hemorrhoidal), a Class II device regulated under 21 CFR 876.4400. Boston Scientific Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 4, 1998
- Date Received
- May 12, 1998
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ligator, Hemorrhoidal
- Device Class
- Class II
- Regulation Number
- 876.4400
- Review Panel
- GU
- Submission Type