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FDA 510(k)

PANOURA 18S

K-Number: K111231 · 2011-07-13

ApplicantThe Yoshida Dental Mfg. Co., Ltd.
Decision Date2011-07-13
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PANOURA 18S is the device name listed in this FDA 510(k) record. The listed applicant is The Yoshida Dental Mfg. Co., Ltd.. It received FDA 510(k) clearance on 2011-07-13 under 510(k) number K111231. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PANOURA 18S?

PANOURA 18S is a medical device that received FDA 510(k) clearance on 2011-07-13. The listed applicant is The Yoshida Dental Mfg. Co., Ltd.. The 510(k) number is K111231.

When did PANOURA 18S receive FDA 510(k) clearance?

PANOURA 18S received FDA 510(k) clearance on 2011-07-13, under 510(k) number K111231.

Who is the listed applicant for PANOURA 18S?

The FDA 510(k) record lists The Yoshida Dental Mfg. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PANOURA 18S?

The FDA product code for PANOURA 18S is MUH.

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Other records listing The Yoshida Dental Mfg. Co., Ltd. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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