FDA 510(k)

SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE

K-Number: K991273 · 1999-08-18

Decision Date1999-08-18

Product CodeMQE

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Swemed Lab International AB. It received FDA 510(k) clearance on 1999-08-18 under 510(k) number K991273. 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 SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE?

SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE is a medical device that received FDA 510(k) clearance on 1999-08-18. The listed applicant is Swemed Lab International AB. The 510(k) number is K991273.

When did SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE receive FDA 510(k) clearance?

SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE received FDA 510(k) clearance on 1999-08-18, under 510(k) number K991273.

Who is the listed applicant for SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE?

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

What is the FDA product code for SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE?

The FDA product code for SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE is MQE.

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Other records listing Swemed Lab International AB as applicant

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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.