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FDA 510(k)

CRYOMEGA

K-Number: K102006 · 2010-10-06

ApplicantStc Consulting, LLC
Decision Date2010-10-06
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYOMEGA is the device name listed in this FDA 510(k) record. The listed applicant is Stc Consulting, LLC. It received FDA 510(k) clearance on 2010-10-06 under 510(k) number K102006. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYOMEGA?

CRYOMEGA is a medical device that received FDA 510(k) clearance on 2010-10-06. The listed applicant is Stc Consulting, LLC. The 510(k) number is K102006.

When did CRYOMEGA receive FDA 510(k) clearance?

CRYOMEGA received FDA 510(k) clearance on 2010-10-06, under 510(k) number K102006.

Who is the listed applicant for CRYOMEGA?

The FDA 510(k) record lists Stc Consulting, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRYOMEGA?

The FDA product code for CRYOMEGA is GEH.

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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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