510(k) K990864
K990864 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228". The FDA issued a decision of Substantially Equivalent on June 11, 1999. The device falls under product code MND (Ligator, Esophageal), 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 11, 1999
- Date Received
- March 16, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ligator, Esophageal
- Device Class
- Class II
- Regulation Number
- 876.4400
- Review Panel
- GU
- Submission Type