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FDA 510(k)

TEMPFLEX

K-Number: K110747 · 2011-06-14

ApplicantKerr Corporation
Decision Date2011-06-14
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEMPFLEX is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation. It received FDA 510(k) clearance on 2011-06-14 under 510(k) number K110747. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMPFLEX?

TEMPFLEX is a medical device that received FDA 510(k) clearance on 2011-06-14. The listed applicant is Kerr Corporation. The 510(k) number is K110747.

When did TEMPFLEX receive FDA 510(k) clearance?

TEMPFLEX received FDA 510(k) clearance on 2011-06-14, under 510(k) number K110747.

Who is the listed applicant for TEMPFLEX?

The FDA 510(k) record lists Kerr Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEMPFLEX?

The FDA product code for TEMPFLEX is EBG.

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Related Devices (Code: EBG)

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Official Source

View on FDA Database →

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

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