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FDA 510(k)

Capiflo 5001

K-Number: K222158 · 2023-01-20

ApplicantK&L Distributing, Inc.
Decision Date2023-01-20
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Capiflo 5001 is a medical device manufactured by K&L Distributing, Inc.. It received FDA 510(k) clearance on 2023-01-20 under approval number K222158. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Capiflo 5001?

Capiflo 5001 is a medical device that received FDA 510(k) clearance on 2023-01-20. It is manufactured by K&L Distributing, Inc.. The 510(k) number is K222158.

When was Capiflo 5001 approved by the FDA?

Capiflo 5001 received FDA 510(k) clearance on 2023-01-20, under approval number K222158.

What company makes Capiflo 5001?

Capiflo 5001 is manufactured by K&L Distributing, Inc..

What is the FDA product code for Capiflo 5001?

The FDA product code for Capiflo 5001 is JOW.

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Official Source

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