FDA 510(k)

SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300

K-Number: K033027 · 2004-08-12

ApplicantShining World Health Care Co., Ltd.

Decision Date2004-08-12

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300 is the device name listed in this FDA 510(k) record. The listed applicant is Shining World Health Care Co., Ltd.. It received FDA 510(k) clearance on 2004-08-12 under 510(k) number K033027. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300?

SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300 is a medical device that received FDA 510(k) clearance on 2004-08-12. The listed applicant is Shining World Health Care Co., Ltd.. The 510(k) number is K033027.

When did SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300 receive FDA 510(k) clearance?

SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300 received FDA 510(k) clearance on 2004-08-12, under 510(k) number K033027.

Who is the listed applicant for SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300?

The FDA 510(k) record lists Shining World Health Care Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300?

The FDA product code for SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300 is GEI.

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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.