SPEEDBAND MULTIPLE BAND LIGATOR— 510(k) K964079

Name: FDA 510(k) clearance K964079
Creator: U.S. Food and Drug Administration
Published: 1997-02-13

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K964079 for SPEEDBAND MULTIPLE BAND LIGATOR, Substantially Equivalent on 1997-02-13. Applicant: Boston Scientific Corp. Device class: 2.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code FHN
Device class: Class 2
Regulation: 21 CFR 876.4400
Advisory panel: Gastroenterology, Urology
Date received: 1996-10-11
Decision date: 1997-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick,, MA, US

Download summary PDF View on FDA.gov ↗

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