FDA.report

510(k) K102856

Device
SIROCCO THERMAL REGULATING SYSTEM
Applicant
GALMAZ BIOTECH S.L.
510(k) number
K102856
Product code
DWJ  
Decision
Substantially Equivalent (SESE)
Decision date
2011-06-30
Date received
2010-09-29
Regulation
870.5900
Classification name
System, Thermal Regulating
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
CHRIS ZANDER
Address
1064 Labarge Hudson WI US 54016 54016

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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