MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM— 510(k) K083335

Substantially Equivalent

Omnisonics Medical Technologies

FDA 510(k) clearance K083335 for MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM, Substantially Equivalent on 2008-12-15. Applicant: Omnisonics Medical Technologies.

Clearance details

Applicant: Omnisonics Medical Technologies
Product code: Code QEY
Advisory panel: Cardiovascular
Date received: 2008-11-12
Decision date: 2008-12-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Wilmington, MA, US

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