RESOLUTION ENDOVASCULAR SYSTEM— 510(k) K052428

Substantially Equivalent

Omnisonics Medical Technologies

FDA 510(k) clearance K052428 for RESOLUTION ENDOVASCULAR SYSTEM, Substantially Equivalent on 2005-12-08. Applicant: Omnisonics Medical Technologies.

Clearance details

Applicant: Omnisonics Medical Technologies
Product code: Code QEY
Advisory panel: Cardiovascular
Date received: 2005-09-02
Decision date: 2005-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, MA, US

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