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FDA 510(k)

SIROCCO THERMAL REGULATING SYSTEM

K-Number: K102856 · 2011-06-30

ApplicantGalmaz Biotech S.L.
Decision Date2011-06-30
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIROCCO THERMAL REGULATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Galmaz Biotech S.L.. It received FDA 510(k) clearance on 2011-06-30 under 510(k) number K102856. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIROCCO THERMAL REGULATING SYSTEM?

SIROCCO THERMAL REGULATING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-06-30. The listed applicant is Galmaz Biotech S.L.. The 510(k) number is K102856.

When did SIROCCO THERMAL REGULATING SYSTEM receive FDA 510(k) clearance?

SIROCCO THERMAL REGULATING SYSTEM received FDA 510(k) clearance on 2011-06-30, under 510(k) number K102856.

Who is the listed applicant for SIROCCO THERMAL REGULATING SYSTEM?

The FDA 510(k) record lists Galmaz Biotech S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIROCCO THERMAL REGULATING SYSTEM?

The FDA product code for SIROCCO THERMAL REGULATING SYSTEM is DWJ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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