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FDA 510(k)

CapKlenZ

K-Number: K192382 · 2020-04-20

ApplicantStar Mountain Medical, Inc.
Decision Date2020-04-20
Product CodeQBP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CapKlenZ is a medical device manufactured by Star Mountain Medical, Inc.. It received FDA 510(k) clearance on 2020-04-20 under approval number K192382. The device is classified under product code QBP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CapKlenZ?

CapKlenZ is a medical device that received FDA 510(k) clearance on 2020-04-20. It is manufactured by Star Mountain Medical, Inc.. The 510(k) number is K192382.

When was CapKlenZ approved by the FDA?

CapKlenZ received FDA 510(k) clearance on 2020-04-20, under approval number K192382.

What company makes CapKlenZ?

CapKlenZ is manufactured by Star Mountain Medical, Inc..

What is the FDA product code for CapKlenZ?

The FDA product code for CapKlenZ is QBP.

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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.

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