FDA 510(k)

Advocate Insulin Pen Needles

K-Number: K160199 · 2016-10-19

ApplicantDiabetic Supply of Suncoast, Inc.

Decision Date2016-10-19

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Advocate Insulin Pen Needles is a medical device manufactured by Diabetic Supply of Suncoast, Inc.. It received FDA 510(k) clearance on 2016-10-19 under approval number K160199. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Advocate Insulin Pen Needles?

Advocate Insulin Pen Needles is a medical device that received FDA 510(k) clearance on 2016-10-19. It is manufactured by Diabetic Supply of Suncoast, Inc.. The 510(k) number is K160199.

When was Advocate Insulin Pen Needles approved by the FDA?

Advocate Insulin Pen Needles received FDA 510(k) clearance on 2016-10-19, under approval number K160199.

What company makes Advocate Insulin Pen Needles?

Advocate Insulin Pen Needles is manufactured by Diabetic Supply of Suncoast, Inc..

What is the FDA product code for Advocate Insulin Pen Needles?

The FDA product code for Advocate Insulin Pen Needles is FMI.

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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.