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FDA 510(k)

SHIKANI SPEAKING VALVE

K-Number: K100995 · 2010-06-25

ApplicantShikani Medical, LLC
Decision Date2010-06-25
Product CodeJOH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SHIKANI SPEAKING VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Shikani Medical, LLC. It received FDA 510(k) clearance on 2010-06-25 under 510(k) number K100995. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHIKANI SPEAKING VALVE?

SHIKANI SPEAKING VALVE is a medical device that received FDA 510(k) clearance on 2010-06-25. The listed applicant is Shikani Medical, LLC. The 510(k) number is K100995.

When did SHIKANI SPEAKING VALVE receive FDA 510(k) clearance?

SHIKANI SPEAKING VALVE received FDA 510(k) clearance on 2010-06-25, under 510(k) number K100995.

Who is the listed applicant for SHIKANI SPEAKING VALVE?

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

What is the FDA product code for SHIKANI SPEAKING VALVE?

The FDA product code for SHIKANI SPEAKING VALVE is JOH.

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Official Source

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