SKYLARK URO PROBE— 510(k) K053007

Substantially Equivalent

Skylark Device & Systems Co., Ltd.

FDA 510(k) clearance K053007 for SKYLARK URO PROBE, Substantially Equivalent on 2005-12-05. Applicant: Skylark Device & Systems Co., Ltd..

Clearance details

Applicant: Skylark Device & Systems Co., Ltd.
Product code: Code KPI
Advisory panel: Gastroenterology, Urology
Date received: 2005-10-26
Decision date: 2005-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

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