510(k) K990864

SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228 by Boston Scientific Corp — Product Code MND

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