Azena Medical, LLC - Oct. 6, 2017
Issue Date
Oct 06, 2017
Region
Pacific
Category
Device
$117.00
Contact Name
Kenneth L. Blanchard
Contact Title
Vice President of Mechanical Engineering
Address 1
3021 Citrus Cir.
Address 2
Ste. 180
City
Walnut Creek
State
CA
Zip/Postal Code
94598
Country
United States
Inspection Range
Oct 04, 2017 - Oct 06, 2017
Pages
2
First Observation
Procedures for design change have not been adequately established.
Investigator(s): Quynh H. Strandberg