510(k) K981669

SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR by Boston Scientific Corp — Product Code FHN

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