REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER— 510(k) K110076

Substantially Equivalent

Sterilmed, Inc.

FDA 510(k) clearance K110076 for REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER, Substantially Equivalent on 2011-08-18. Applicant: Sterilmed, Inc..

Clearance details

Applicant: Sterilmed, Inc.
Product code: Code OWQ
Advisory panel: Cardiovascular
Date received: 2011-01-11
Decision date: 2011-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

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