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FDA 510(k)

PERFADEX WITH THAM

K-Number: K081997 · 2008-10-09

ApplicantVitrolife Sweden AB
Decision Date2008-10-09
Product CodeMSB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PERFADEX WITH THAM 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 2008-10-09 under 510(k) number K081997. The device is classified under product code MSB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERFADEX WITH THAM?

PERFADEX WITH THAM is a medical device that received FDA 510(k) clearance on 2008-10-09. The listed applicant is Vitrolife Sweden AB. The 510(k) number is K081997.

When did PERFADEX WITH THAM receive FDA 510(k) clearance?

PERFADEX WITH THAM received FDA 510(k) clearance on 2008-10-09, under 510(k) number K081997.

Who is the listed applicant for PERFADEX WITH THAM?

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 PERFADEX WITH THAM?

The FDA product code for PERFADEX WITH THAM is MSB.

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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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