SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL


Device Classification Name

ligator, hemorrhoidal

510(k) Number K000397
Device Name SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL
Original Applicant
BOSTON SCIENTIFIC CORP.
one boston scientific place
natick, 
MA 
01760 -1537

Original Contact abby lipman
Regulation Number 876.4400
Classification Product Code
FHN  
Subsequent Product Code
MND  
Date Received 02/07/2000
Decision Date 03/07/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Special
Reviewed by Third Party No

Combination Product

No