FDA 510(k) Premarket Notification K000397: SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL

Submission Details & Decision

Normalized public record details for 510(k) notification K000397.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K000397

Applicant / Sponsor

Boston Scientific Corp

Device Name

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

Product Code

FHN

Decision Date

2000-03-07

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Gastroenterology, Urology (GU)

Clearance Type

Special

Third Party Flag

Date Received

2000-02-07

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