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FDA 510(k)

CRYONIZE TM

K-Number: K103310 · 2011-02-09

Applicant3jt Enterprises, LLC
Decision Date2011-02-09
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYONIZE TM is the device name listed in this FDA 510(k) record. The listed applicant is 3jt Enterprises, LLC. It received FDA 510(k) clearance on 2011-02-09 under 510(k) number K103310. 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 CRYONIZE TM?

CRYONIZE TM is a medical device that received FDA 510(k) clearance on 2011-02-09. The listed applicant is 3jt Enterprises, LLC. The 510(k) number is K103310.

When did CRYONIZE TM receive FDA 510(k) clearance?

CRYONIZE TM received FDA 510(k) clearance on 2011-02-09, under 510(k) number K103310.

Who is the listed applicant for CRYONIZE TM?

The FDA 510(k) record lists 3jt Enterprises, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRYONIZE TM?

The FDA product code for CRYONIZE TM 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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