Sivantos Co., Ltd. - April 16, 2015
Issue Date
Apr 16, 2015
Region
HQ
Category
Device
$117.00
Contact Name
Fu Jian Tong
Contact Title
CEO
Address 1
No. 120 Su Tong Rd.
Address 2
China-Singapore Suzhou Industrial Park
City
Suzhou
Zip/Postal Code
215021
Country
China
Inspection Range
Apr 13, 2015 - Apr 16, 2015
Pages
3
First Observation
The device history record does not demonstrate that the device was manufactured in accordance with the device master record.
Investigator(s): Frank J. Marciniak