Boule Medical AB - February 6, 2014
Issue Date
Feb 06, 2014
Region
HQ
Category
Device
$117.00
Contact Name
Claes G.T. Blanche
Contact Title
President
Address 1
Vastberga Alle 32
City
Stockholm
Zip/Postal Code
SE-126 13
Country
Sweden
Inspection Range
Feb 03, 2014 - Feb 06, 2014
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): Thai Duong