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FDA 510(k)

SPERMFREEZE SOLUTION

K-Number: K113786 · 2012-10-26

ApplicantVitrolife Sweden AB
Decision Date2012-10-26
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SPERMFREEZE SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Vitrolife Sweden AB. It received FDA 510(k) clearance on 2012-10-26 under 510(k) number K113786. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPERMFREEZE SOLUTION?

SPERMFREEZE SOLUTION is a medical device that received FDA 510(k) clearance on 2012-10-26. The listed applicant is Vitrolife Sweden AB. The 510(k) number is K113786.

When did SPERMFREEZE SOLUTION receive FDA 510(k) clearance?

SPERMFREEZE SOLUTION received FDA 510(k) clearance on 2012-10-26, under 510(k) number K113786.

Who is the listed applicant for SPERMFREEZE SOLUTION?

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

What is the FDA product code for SPERMFREEZE SOLUTION?

The FDA product code for SPERMFREEZE SOLUTION is MQL.

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Related Devices (Code: MQL)

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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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