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FDA 510(k)

Non-Telescopic PenEvac

K-Number: K160160 · 2016-04-05

ApplicantI.C Medical, Inc.
Decision Date2016-04-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Non-Telescopic PenEvac is a medical device manufactured by I.C Medical, Inc.. It received FDA 510(k) clearance on 2016-04-05 under approval number K160160. 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 Non-Telescopic PenEvac?

Non-Telescopic PenEvac is a medical device that received FDA 510(k) clearance on 2016-04-05. It is manufactured by I.C Medical, Inc.. The 510(k) number is K160160.

When was Non-Telescopic PenEvac approved by the FDA?

Non-Telescopic PenEvac received FDA 510(k) clearance on 2016-04-05, under approval number K160160.

What company makes Non-Telescopic PenEvac?

Non-Telescopic PenEvac is manufactured by I.C Medical, Inc..

What is the FDA product code for Non-Telescopic PenEvac?

The FDA product code for Non-Telescopic PenEvac is GEI.

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Official Source

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