AUSCO ES-3100— 510(k) K070550

Substantially Equivalent

Koratek Company, Ltd.

FDA 510(k) clearance K070550 for AUSCO ES-3100, Substantially Equivalent on 2007-11-06. Applicant: Koratek Company, Ltd..

Clearance details

Applicant: Koratek Company, Ltd.
Product code: Code DQD
Advisory panel: Cardiovascular
Date received: 2007-02-27
Decision date: 2007-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

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