510(k) K082242— ICON, MODEL C3

Substantially Equivalent

Osypka Medical, Inc.

Clearance details

Applicant: Osypka Medical, Inc.
Product code: Code DSB
Advisory panel: Cardiovascular
Date received: 2008-08-07
Decision date: 2008-10-08
Decision: Substantially Equivalent
Clearance type: Special
Location: La Jolla, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.