FDA 510(k)

FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN

K-Number: K082727 · 2009-02-06

Decision Date2009-02-06

Product CodeMQE

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN 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 2009-02-06 under 510(k) number K082727. The device is classified under product code MQE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN?

FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN is a medical device that received FDA 510(k) clearance on 2009-02-06. The listed applicant is Vitrolife Sweden AB. The 510(k) number is K082727.

When did FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN receive FDA 510(k) clearance?

FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN received FDA 510(k) clearance on 2009-02-06, under 510(k) number K082727.

Who is the listed applicant for FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN?

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 FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN?

The FDA product code for FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN is MQE.

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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.