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FDA 510(k)

A3F FRATIONAL

K-Number: K122200 · 2013-04-18

ApplicantPollogen, Ltd.
Decision Date2013-04-18
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

A3F FRATIONAL is the device name listed in this FDA 510(k) record. The listed applicant is Pollogen, Ltd.. It received FDA 510(k) clearance on 2013-04-18 under 510(k) number K122200. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A3F FRATIONAL?

A3F FRATIONAL is a medical device that received FDA 510(k) clearance on 2013-04-18. The listed applicant is Pollogen, Ltd.. The 510(k) number is K122200.

When did A3F FRATIONAL receive FDA 510(k) clearance?

A3F FRATIONAL received FDA 510(k) clearance on 2013-04-18, under 510(k) number K122200.

Who is the listed applicant for A3F FRATIONAL?

The FDA 510(k) record lists Pollogen, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A3F FRATIONAL?

The FDA product code for A3F FRATIONAL is GEI.

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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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