AGGREGUIDE— 510(k) K122162

Substantially Equivalent

Aggredyne, Inc.

FDA 510(k) clearance K122162 for AGGREGUIDE, Substantially Equivalent on 2013-12-20. Applicant: Aggredyne, Inc..

Clearance details

Applicant: Aggredyne, Inc.
Product code: Code JOZ
Advisory panel: Hematology
Date received: 2012-07-20
Decision date: 2013-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

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